2 6 t h A n n u a l EuroMeeting V i e n n a 2014
25-27 March 2014 ACV, Vienna, Austria
For more information and to register visit www.diahome.org/EM2014 Final Programme 2
Table of Contents Continuing Professional Development Credits...... 2 Theme 10 | Globalisation/Inspections...... 34-35 Programme Advisors...... 2 Theme 11 | Regulation of Medical Devices and Combination Products...... 36 Welcome from the EuroMeeting 2014 Co-Chairs...... 3 Theme 12 | Pharmaceutical Quality in the 21st Century...... 36-37 EuroMeeting 2014 Theme Leaders...... 4 Theme 13 | The Role of Transparency and Ethics: Legal Perspectives...... 37-38 Schedule at a glance...... 5 Theme 14| Innovation in R&D Models...... 39-40 A-Z General Information...... 6-7 Theme 15 | New and Known Active Substances - how to fit the rules to needs. 40-41 Opening Plenary...... 8 Theme 16 | Knowledge Management and Regulatory/ Special Sessions...... 9 Competitive Intelligence...... 41-42 Student Posters/Professional Posters/Fellowship Programmes...... 12-14 Hot Topics and Stand-Alone Sessions...... 42-43 Pre-Conference Tutorials...... 16-19 Focus Sessions...... 44 Young Professional/Student Tutorials...... 20 Speaker Index...... 45-51 Theme 1 | Regulatory Science...... 22-23 EuroMeeting 2014 Glossary ...... 53 Theme 2 | HTA/Regulatory Interface...... 24-25 Exhibition...... 55-66 Theme 3 | Benefit/Risk Management and Lifecycle Approach...... 26-27 Networking Events ...... 54 Theme 4 | Special Populations...... 28 ACV Floor Plans...... 72-73 Theme 5 | Personalised Medicine: Drug-Companion Diagnostics Combinations...... 29 EuroMeeting Session Plan...... 74-76 Theme 6 | Clinical Research...... 30-31 About the EuroMeeting/about Vienna...... 77 Theme 7 | eClinical Reaching Out...... 31-32 Theme 8 | Innovation in Healthcare and its Impact on Industry...... 32-33 Theme 9 | Involving and Informing Patients...... 33
Continuing Professional Development Credits DIA meetings are accredited by the SwAPP (Swiss Association of Pharmaceutical Professionals) Commission for Professional Development (CPD) and SGPM (Swiss Society of Pharmaceutical Medicine). All participants are eligible for these credits and certificates are available on request from the registration desk.
The 26th Annual EuroMeeting is expected to be awarded up to 14 CPD credits from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK. Medical practitioners who are eligible for credits can click on http://www.fpm.org.uk/cpd/registration for more information. If you are already a CPD member, please go directly to http://cpd.fpm.org.uk to claim your credits.
EuroMeeting Quick Facts Disclosure Statement
• Neutral, global forum featuring over 110 sessions attracting more than 3,000 professionals involved Unless otherwise disclosed, DIA Europe acknowledges in the development of medicines from more than 50 countries that the statements made by speakers are their own • Speakers from the European Medicines Agency, the European Commission, the FDA and other opinion and not necessarily that of the organisation they represent, or that of DIA Europe. Speakers and regulatory agencies from European countries and other regions of the world agenda are subject to change without notice. • More than 170 exhibitors on one of the largest exhibition floors in Europe • Unparalleled multi-disciplinary networking opportunities Recording of any DIA Europe tutorial/workshop/ • Student and professional poster sessions session information in any type of media is prohibited • Active involvement of patient organisations without prior written consent from DIA Europe. • Pre-conference tutorials led by expert faculty • Hot topics
Programme Advisors Emer Cooke, Head of International Affairs, European Medicines Agency, EU Craig Johnson, Senior Director, Global Regulatory Affairs, GlaxoSmithKline, UK Stefano Marino, Head of Sector, Legal Services, European Medicines Agency, EU Maria Mavris, Director Therapeutic Development, EURORDIS, France Detlef Nehrdich, Senior Associate, Waife and Associates Inc., Germany Ilona Reischl, Senior Assessor, Austrian Medicines and Medical Devices Agency (AGES), Austria Alexander Roediger, Director European Union Affairs, MSD Europe, Inc., Belgium Ad Schuurman, Head of Reimbursement Department, Health Care Insurance Board (CVZ) Chair of MEDEV, the Netherlands Eva-Maria Zebedin-Brandl, Institute for Pharmacology, Medical University of Vienna, Austria Pēteris Zilgalvis, Head of Unit, Health and Well Being, Directorate General Communications Networks, Content and Technology. European Commission, EU EuropaBio Association, Topic Group, Belgium EU Regulatory Intelligence Network Group (EU RING) EuroMeeting 2014 Co-Chairs’ message 3
Welcome from the EuroMeeting 2014 Co-Chairs
Dear Participant,
We are excited to welcome you to the DIA EuroMeeting 2014 in Vienna. Located right in the geographical centre of the European Union, Vienna is an ideal place to come together to discuss and reflect on different perspectives from north to south and east to west.
Vienna is a city that relishes its past, and it has the attractions to prove it. There is a long tradition of classical music performed every day in the opera houses and concert halls. Vienna’s rich history of art, from the fine arts to great architecture, such as the “Hundertwasserhaus”, is visible all over the city to inspire your mind. In addition to its beautiful surroundings, Vienna offers many culinary delights and places to enjoy good food and wine. This welcoming atmosphere will pleasantly enhance your unique DIA Euromeeting experience.
This meeting’s motif is ‘Different perspectives – one vision: Better healthcare for patients’. We are putting patients' rights in the centre of our discussions and broadly encourage their contribution to all themes. Better healthcare for patients is our common goal. Although you may hold your own views on the current issues linked to your specific role in the system, the meeting will offer a special opportunity to actively listen to other stakeholders’ perspectives and enlarge your own horizon. We strongly believe that as the complexity of the issues has dramatically increased, and everyone needs to know what is happening in other areas or disciplines to better anticipate potential impacts of decisions down the line. This cross-fertilisation and inclusiveness of the debates will hopefully generate better understanding of each other’s perspectives and allow the generation of new ideas to achieve our common goal. As such, this can be our contribution to innovation in healthcare.
Over the years, this conference has become a real centre of attention for regulatory professionals and related life science experts. We are proud to have attracted a number of very high level speakers from institutions including the European Commission, Heads of National Regulatory Agencies and the European Medicines Agency. Furthermore, we are delighted to have attracted additional views from outside Europe including international speakers from the agencies in the US and Japan.
We truly believe that anyone who wants to understand the trends of the healthcare and regulatory environment for medical products and medical devices will be fascinated to listen to and engage in the discussions.
Angelika Joos and Christa Wirthumer-Hoche
programme co-chairs
Angelika Joos Executive Director, Global Regulatory Policy, Merck Sharp and Dohme, Belgium
Angelika Joos is a licensed pharmacist. Since 2001, she is responsible for regulatory policy issues at Merck Sharp & Dohme's Regulatory Affairs department in Brussels. Over the past 17 years, Angelika has gained strategic as well as operational experience with all regulatory procedures and various products in different therapeutic areas.
In her current position as Head Regulatory Policy EU & Most of World she has been responsible for monitoring and implementing regulatory policies and procedures and advising the company on regulatory strategies. She represents MSD in the EFPIA Scientific Regulatory and Manufacturing Policy Committee and in the IFPMA Regulatory Policy Committee. Her main interests are related to clinical trials, pharmacovigilance, HTA and paediatrics.
She has been a member of the DIA Advisory Council Europe since 2008 and has been involved in the organisation of several DIA Forums as well as two DIA EuroMeetings.
Christa Wirthumer-Hoche Head of Austrian Medicines and Medical Devices Agency, Austria
Dr. Christa Wirthumer-Hoche studied biochemistry and graduated from the Technical University, Vienna in 1981. She did her doctoral thesis at the Institute for Medical Physiology, graduating in 1983 then joined the Austrian National Institute for Quality Control of Drugs in 1983, focusing on the assessment of quality documentation. From June 1998 until December 2005 she was the Head of the Licensing Division for medicinal products, in the Unit for Pharmaceutical Affairs in the Austrian Federal Ministry of Health and Women.
Since the founding of the new Austrian Agency 1 January 2006 her position is Head of Institute for Marketing Authorisation and Lifecycle Management of Medicinal Products and she was appointed Head of the Austrian Medicines and Medical Devices Agency on 1 October 2013.
Dr. Wirthumer-Hoche has also been involved in different European committees and working groups (CPMP/CVMP Quality Working Party, the Committee for Proprietary Medicinal Products (CPMP), MRFG, Notice to Applicants Group, in the PERF project). In Dec.1999 she was appointed by the European Commission as Co-ordinator for the CTD Implementation in Europe (ICH-IWG). She is the Austrian Delegate in the Coordination Group for Mutual Recognition and Decentralised Procedures for human MPs (CMD-h) and chair of the Joint Working Group on ASMF-procedures. 4 EuroMeeting 2014 THEME LEADERS
Anna Bucsics Peter Høngaard Andersen Lembit Rägo Former Department Head, Department CEO, Høngaard Consulting, Denmark Coordinator, Quality Assurance and of Pharmaceuticals Affairs, Main Safety for Medicines, Essential Medicines Association of Austrian Social Security and Health Products, WHO, Switzerland Institutions, Austria
Salah-Dine Chibout Wills Hughes-Wilson Kristin Raudsepp Global Head Discovery & Investigative Safety, Vice President External Affairs, Chief Director General of State Agency for Global Head Preclinical Safety Therapeutic Patient Access Officer, Sobi, Sweden Medicines, Estonia Areas, Novartis Pharma, Novartis Institutes for BioMedical Research, Switzerland
Graham Cook Tim Kievits Tomas Salmonson Senior Director, Process Knowledge/ Director Healthcare Innovation, Vitromics Chair Committee for Medicinal Products Quality by Design, Global Quality Healthcare, the Netherlands for Human Use (CHMP), Senior Scientific Strategy, Pfizer, UK Advisor, Medical Products Agency (MPA) Sweden
Judith Creba Vesna Koblar Valerie Simmons Head EU Liaison & Policy, Novartis Director, Pharmaceutical Regulatory EU QPPV, Global Patient Safety, Eli Lilly Pharma, Switzerland Affairs Consulting and Education & Company, UK (raPHARM), Slovenia
Christopher Foreman Marianne Köhne Peter Stokman Senior Director Legal Affairs, Scandinavia Global Regulatory Affairs/RCC Head Global Data Management & & Baltic, Merck Sharp and Dohme, Coordinator, Boehringer Ingelheim, Standards Oss, Merck Sharpe and Belgium Germany Dohme, the Netherlands
Nick Sykes Hans-Georg Eichler Geneviève Michaux Senior Director Senior Medical Officer, European of Counsel, Hunton & Williams Belgium Worldwide Safety and Regulatory, Pfizer, Medicines Agency, EU UK
Hans van Bruggen Shayesteh Fürst-Ladani Carl Naraynassamy Director, eCTDConsultancy, Image Managing Director, SFL Regulatory Director, Explicator, Ltd., UK the Netherlands not Affairs and Scientific Communication, available Switzerland
Christa Wirthumer-Hoche Jan Geissler Estelle Michael Head of Austrian Medicines and Medical Director, The European Patients’ Senior Director, Policy and Intelligence, Devices Agency, Austria Academy on Therapeutic Innovation Europe and International Regulatory (EUPATI) Policy, Intelligence, AstraZeneca, UK Belgium
Clara Heering Terje Peetso Vice President Clinical Risk Management, Policy Officer, Directorate General ICON Clinical Research, Belgium Communications Networks, Content and Technology, European Commission, EU
STAY CONNECTED
Stay Connected at Stay Connected at Stay Connected at DIA Europe #EuroMeeting2014 https://www.facebook.com/DIA.Europe Community on Linkedin 2 6 t h A n n u a l EuroMeeting V i e n n a 2014
SCHEDULE at a glance
monday, 24 March 2014 wednesday, 26 MARCH 2014
Registration Hours: Registration Hours: 09:00-18:00 Exhibitor Registration and Set-up 08:00-18:30 Attendee, Speaker and Exhibitor Registration 15:00-18:00 Attendee and Speaker Registration Avoid the rush on Tuesday by picking up your Schedule: badge and conference material on Monday afternoon 08:00-09:00 Welcome Coffee 17:30-18:30 Students and Young Professionals Welcome Reception 09:00-18:30 Exhibition Open 09:00-10:30 Session 1 - Choose from Parallel Sessions 10:15-11:00 Coffee Break in the Exhibition Hall tuesday, 25 MARCH 2014 11:00-12:30 Session 2 - Choose from Parallel Sessions 12:00-14:00 Lunch in the Exhibition Hall Registration Hours: 12:30-13:15 DIA Communities - Meet and Eat 08:00-18:30 Attendee, Speaker and Exhibitor Registration 13:30-14:00 Speed Networking 07:30-11:00 Exhibitor Set-up 14:00-15:30 Session 3 - Choose from Parallel Sessions 14:00-15:30 Exhibition Guest Passes Schedule: 15:15-16:00 Coffee Break in the Exhibition Hall 09:00-12:30 Pre-Conference Tutorials 16:00-17:30 Session 4 - Choose from Parallel Sessions 09:00-12:30 Student Tutorial 17:30-18:30 The Wednesday Reception in the Exhibition Hall 09:00-12:30 Young Professional Tutorial 17:45-18:15 Student Poster Award Ceremony at the DIA Booth 10:30-11:00 Pre-Conference Tutorials Coffee Break 12:00-14:00 Lunch in the Exhibition Hall 12:00-19:00 Conference and Exhibition Open thursday, 27 MARCH 2014 12:45-13:45 Patient Representatives Lunch 14:00-17:15 Opening Plenary Session Registration Hours: 15:00-15:45 Coffee Break in the Exhibition Hall 08:00-17:30 Attendee, Speaker and Exhibitor Registration 17:30-19:00 Welcome Reception and Award Ceremony in the Exhibition Hall Schedule: 08:00-09:00 Welcome Coffee 09:00-16:00 Exhibition Open 09:00-10:30 Session 5 - Choose from Parallel Sessions 10:15-11:00 Coffee Break in the Exhibition Hall Exhibition Hall Hours 11:00-12:30 Session 6 - Choose from Parallel Sessions 12:00-14:00 Lunch in the Exhibition Hall Tuesday, 25 March 2014 12:00 – 19:00 12:00-14:00 Student Feedback Lunch Wednesday, 26 March 2014 12:00-14:00 Patient Fellowship Feedback Lunch 09:00 – 18:30 | Exhibition Guest Passes 14:00 – 15:30 14:00-15:30 Session 7 - Choose from Parallel Sessions Thursday, 27 March 2014 15:15-16:00 Coffee Break in the Exhibition Hall 09:00 – 16:00 16:00-17:30 Session 8 - Choose from Parallel Sessions 17:30 End of Conference 6
A-Z of General Information Attendee Lounge | Exhibition Hall The Attendee Lounge on the Exhibition Hall offers comfortable seating for The 26th Annual EuroMeeting takes place at the: conference participants to rest their feet, meet with colleagues or contacts, or catch up on emails. See Exhibition for opening hours. Austria Center Vienna (ACV) Bruno-Kreisky-Platz 1 Banking/ATM | Entrance Hall 1220 Vienna - Austria There is a cash dispenser in the main entrance hall OE.
Transportation to the AustrianCenter Vienna (ACV) Business Center ACV Vienna - Excellent location, easy to reach! Please note that there is no business center within the ACV. There are two copy 7 minutes from the historic city center (by underground U1) shops within walking distance of the ACV: 30 minutes from Vienna International Airport to the conference center 1. 17 Repa Copy Wien IZD Tower By Plane Wagramer Strasse 19, Vienna There are a number of ways to travel into the city from Vienna International Airport. But we ask all of our visitors to think of the environment and use public 2. Repa Copy Wien EastSide transport wherever possible. Donau-City-Strasse 4, Vienna
City Airport Train CAT www.repacopy.at • 16 minutes to Landstrasse/Wien Mitte station • Frequency: every 30 minutes Café | Entrance Hall OE • Airport check-in at the Wien Mitte City Air Terminal The Academia Cafe is a pay-cafe selling drinks and snacks to keep you refreshed • Tickets: single EUR 12 return EUR 19 throughout the day located in the main entrance on level OE. www.cityairporttrain.com Tuesday 12:30 - 17:30 Rail S-bahn commuter railway (S7) Wednesday 08:30 - 15:30 • 27 minutes to Landstrasse / Wien Mitte station Thursday 08:30 - 15:30 • Frequency: every 30 minutes during the day • Tickets: single EUR 4.30 Certificate of Attendance | Entrance Hall www.oebb.at A Certificate of Attendance can be printed at the Scan-and-Go desks in the registration area on Thursday. Bus: airport shuttle • Direct service to the Austria Center Vienna: 30 minutes (stop: Wien Cloakroom/Baggage | Entrance Hall Kaisermühlen-Kagran) The cloakroom is in the Entrance Hall on Level OE. There is a charge of € 2.40 • City center: 17–45 minutes (other stops: Schwedenplatz, Wien Meidling, Wien per item Westbahnhof) • Frequency: every 30-60 minutes during the day Tuesday 08:00 - 19:30 • Tickets: Single EUR 8, return EUR 13 Wednesday 08:00 - 19:30 www.viennaairportlines.at Thursday 08:00 - 18:00
The city has five different underground lines. The U1 will take you from Conference Bags | Entrance Hall Stephansplatz to Kaisermühlen VIC and the Austria Center Vienna is just a few All attendees with a full meeting registration can collect a conference bag from minutes’ walk from the station. the Conference Bag Distribution Point in the entrance hall on level OE. Please bring the bag voucher you received when you collect your badge. Taxi The airport is located directly on the A4 motorway. It takes around 25 minutes to DIA Booth | Exhibition Hall reach the Austria Center by taxi. Find out more about all DIA can offer you. Stop by the DIA Booth on the Exhibition • 25 minutes to the Austria Center Vienna Floor. See Exhibition for opening hours • Price: around EUR 36 DIA Patient Fellowship Booth | Exhibition Hall Limousine service DIA actively promotes the involvement of patients’ representatives in the A private limousine service is also available to make the journey to and from the EuroMeeting. Since 2006, more than 200 patients’ representatives have been Austria Center Vienna even more comfortable. involved as participants, speakers, session chairs, and also in the Programme http://www.easymotion.at/limousines Committee. The Patient Fellowship Booth acts as a focal point for patient fellows and other stakeholders to meet and network. Getting around by public transport Vienna has a fully integrated public transport network consisting of 5 underground Exhibition | Exhibition Hall lines, 28 tram routes and more than 100 bus routes. With many new companies exhibiting this year, the EuroMeeting exhibition offers • Frequent services: waits of just 3-5 minutes at peak times, rising to between 5 more opportunities than ever to connect with attendees. and a maximum of 15 minutes in the evenings. • Operating times: 05:00-00:30, night service on weekends (Fri and Sat night Tuesday 12:00 - 19:00 and the nights before public holidays) 00:30-05:00 Wednesday 09:00 - 18:30 | Public Access 14:00 - 15:30 Thursday 09:00 - 16:00
Please see the exhibit floor-plan on page 55 and list of exhibiting companies on page 56-57. 7
Exhibitor Services | Exhibition Hall Presentations The Exhibitor Services Desks are located in the entrance of the exhibition hall. See Full conference attendees will have access to presentations and session Exhibition for opening hours. recordings at no additional cost until 30 June 2014. To extend access after that date, purchase the Premium Upgrade at the discounted attendee rate. More First Aid | Level OE information and rates will be available after the conference. Please contact DIA A medical professional will be on duty during conference hours. Contact the Europe at [email protected]. Information Desk in the entrance hall for assistance. Alternatively, any staff member or DIA host/hostess will be more than happy to be of assistance. Press Office | Exhibition Hall Opening Hours: Get Involved in DIA | Exhibition Hall Find out how you can propose an educational idea, volunteer to speak, join a Tuesday 12:00 - 19:00 DIA Community, submit an article for publication and lots more at the DIA booth. Wednesday 09:00 - 18:30 Thursday 09:00 - 16:00 Tuesday 12:30 - 19:00 Refreshments | Exhibition Hall Wednesday 10:00 - 18:30 Refreshments and Lunch will be served each day on the Exhibition Floor. New this Thursday 10:00 - 16:00 year: all coffee breaks and lunches have been extended!
Information Desks | Entrance Hall Tuesday If you have any questions about the EuroMeeting, from finding session rooms to 12:00-14:00 Lunch networking activities, stop by the DIA Information Desk in the entrance hall. 15:00-15:45 Afternoon tea/coffee with snack Alternatively, any staff member or DIA host/hostess will be more than happy to be of assistance. Wednesday 10:15-11:00 Morning tea/coffee with snack Tuesday 08:00 - 19:00 12:00-14:30 Lunch Wednesday 08:00 - 18:00 15:15-16:00 Afternoon tea/coffee with snack Thursday 08:00 - 16:00 Thursday 10:15-11:00 Morning tea/coffee with snack Internet Access 12:00-14:00 Lunch Permanent workstations will be available in the Cyber Café located in the 15:15-16:00 Afternoon tea/coffee with snack exhibition hall in the Exhibition Hall. Wireless access is available throughout the conference center. Water dispensers are located around the Exhibition Hall.
Lost and Found | Entrance Hall Registration | Entrance Hall All items will be stored at the Information Desk in the entrance hall until the end Registration is located in the main entrance hall and will be open as follows: of the conference. Monday 15:00 - 18:00 Tuesday 08:00 - 18:30 Members Lounge Wednesday 08:00 - 18:30 V.I.P. Feeling for DIA Members Thursday 08:00 - 17:30 DIA Members can relax in the Members-only Lounge in the Exhibition Hall during breaks, or whenever a few minutes in a quiet setting is needed. Coffee and drinks Security are served throughout exhibition opening hours and charging stations for your We take the safety of our participants very seriously. Please help us by cooperating electronic devices are available. Make sure you bring your new membership card fully with the security personnel on duty and wear your badge at all times. Only to identify yourself as a DIA Member at the desk. Access exclusively for DIA participants with a valid conference badge will be allowed into the ACV. Members. Speaker Resource Center | Foyer F – Level OE Note: if you have not yet received your new membership card, have it printed All speakers are required to visit the Speaker Resource Center in the ACV Vienna onsite at the DIA Booth. and re-check their slides at least 2 hours before the start of their session(s). Monday 15:00- 18:00 Messaging Services Tuesday 08:00- 18:00 Download the DIA App for iPhone and Android devices. Sign in to the EuroMeeting Wednesday 08:00- 18:00 section. Thursday 08:00- 16:00
A mobile web version is also available for BlackBerry. See the EuroMeeting Extra Tourism Information Foyer | Exhibition Hall publication in your conference bag or ask for further information at a EuroMeeting The Convention Bureau Vienna will be present in the exhibition hall. They will be Information Desk. happy to provide you with all the information you need to make the most of your stay in Vienna. Search for “DrugInfoAssn” in your iTunes or PlayStore. Tuesday 12:00 – 19:00 Posters | Exhibition Hall Wednesday 10:00 – 16:30 Student, professional and patient representative posters will be displayed in the Exhibition Hall. Alternatively, visit http://www.vienna.convention.at
Come and talk to our student poster presenters during lunchtime on Tuesday Twitter between 13:00-14:00. A selected group of professional poster presenters will Tweet about the EuroMeeting using #EuroMeeting2014 and @DIA_Europe share their research results in various topics. Visit the Exhibition Hall to view the Posters.
Join us at the DIA booth on the Exhibition Floor for the Student Poster Award Ceremony on Wednesday, 26 March at 17:45. 8 opening plenary
VIENNA 2014 Opening Plenary TUESDAY | 25 March 2014 | 14:00 – 17:15
Conference Opening Alois Stöger, Minister of Health, Austria
Keynote address Ilona Kickbusch, Director of the Global Health Programmme at the Graduate Institute of International and Development Studies, Switzerland
Panel Discussion Sustainable Health Systems – Did we think about the citizen?
Healthcare is usually designed around and for, but seldom with, citizens and patients – despite the fact that prevention activities or treatment highly depend on their collaboration. The panel discussion will be about the role of citizens and patients in healthcare and health systems. It will discuss what policies are needed to create more participative health systems, e.g. health literacy, how broader stakeholder involvement can address challenges in access, health outcomes, and how citizen- and patient-centred policies can contribute to sustainable health systems in the future.
Moderator: Peter O’Donnell, Associate Editor, European Voice, Belgium
Panel Nicola Bedlington, Executive Director, European Patients Forum, Belgium Anna Bucsics, Former Department Head, Department of Pharmaceuticals Affairs, Main Association of Austrian Social Security Institutions, Austria Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Mike Rosenblatt, Executive Vice President and Chief Medical Officer, Merck & Co., USA Andrzej Rys, Director of Health Systems and Products, European Commission, EU
Closing Remarks Ilona Kickbusch, Director of the Global Health Programmme at the Graduate Institute of International and Development Studies, Switzerland
DIA would like to thank our Media Partners! special sessions 9
Regulatory Town Hall Meeting Japanese Regulatory Session/PMDA Update
Session 0103 | Wednesday, 26 March, 14:00-15:30 | B-O2 Session 1706 | Thursday, 27 March, 11:00-12:30 | G-U2
REGULATORY TOWN HALL MEETING Session Chair: Session Co-Chairs: Nobumasa Nakashima, Director, Office of International Programs, Guido Rasi, Executive Director, European Medicines Agency, EU Pharmaceuticals and Medical Devices Agency (PMDA), Japan Christa Wirthumer-Hoche, Head, Austrian Medicines and Medical Devices The PMDA will explain its current services and the Japanese drug regulation Agency (AGES), Member CMDh, Austria and answer questions on these and PMDA’s future initiative / challenges for At the Town Hall Meeting attendees can put burning questions to expert faster review and better life cycle management of drugs. regulators about these topics: Tatsuya Kondo, Pharmaceuticals and Medical Devices Agency, Chief Executive • Transparency Officer, Japan • Implementation of the Pharmacovigilance Legislation • Latest Changes to the Clinical Trial Legislation Taka Yamori, Director or Center for Product Evaluation, Pharmaceuticals and • Innovation - Products in the pipeline Medical Devices Agency (PMDA), Japan • EU-enlargement with Croatia Hiroshi Yamamoto, Chief Safety Officer, Pharmaceuticals and Medical Devices Ian Hudson, Chief Executive, MHRA, UK Agency, Japan June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, MHRA, UK Andrzej Rys, Director of Health Systems and Products, European Commission, EU Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products Agency (MPA) Sweden Viola Macolic Sarinic, Head of Agency, Agency for Medicinal Products and Medical Devices (HALMED), Croatia Walter Schwerdtfeger, President, Federal Institute for Drugs and Medical Devices (BfArM), Germany
AustriaN Satellite Meeting briefing on Advanced Therapy Medicinal Products Session 1900 | Tuesday, 25 March, 11:00 - 12:30 | K-U2 Session LB01 | Thursday, 27 March 12:45 - 13:45 | 12-U2 AUSTRIA - AN ATTRACTIVE RESEARCH AND BUSINESS LOCATION Moderator: Briefing on Advanced Therapy Medicinal Products Heinrich Klech, President and CEO, Medical School of Vienna, Austria THE HOSPITAL EXEMPTION FOR ADVANCED THERAPIES: CAN WE BRIDGE THE GAP BETWEEN LOCAL TREATMENTS AND PAN-EUROPEAN STAN- Cooperation and interaction between the Austrian Medicines and Medical DARDISED THERAPIES? Devices Agency, Academia and the Austrian Pharma Industry will be topics Session Chair: for discussion. Matthias Wilken, Hear Regulatory Affairs Europe, German Pharmaceutical Industry Association (BPI), Germany Positioning of the Austrian Medicines and Medical Devices Agency in the EU Network The implementation of the ATMP Regulation (1394/2007), and in particular Christa Wirthumer-Hoche, Head, Austrian Medicines and Medical Devices the application of the so-called Hospital Exemption, proved a matter of debate Agency (AGES) amongst stakeholders. Whilst the Hospital Exemption delivers innovative and Clinical Research in Austria customised therapies to individual patients at local level, it is perceived to have Markus Müller, Vice Rector, Medical University of Vienna the potential to undermine the development of centrally authorised ATMPs.
OKids – Austrian Paediatric Research Network Although it is still unknown whether the Commission will revise the ATMP Christoph Male, Associate Professor of Paediatrics, Medical University of Regulation or not, this session will look into possible ways to have a balanced Vienna approach to the Hospital Exemption, taking into account patients’ needs, regulatory requirements, and medical Innovation Biologics R&D in Austria: Innovation and sustainable patient access Joerg Windisch, Chief Science Officer, Sandoz Biopharmaceuticals, Austria Regulator’s View Biotech Manufacturing of Life-Saving Biologicals in Austria Paula Salmikangas, Vice-Chair CAT, Senior Researcher, Finnish Medicines Karl-Heinz Hofbauer, Director, Baxter Bioscience Agency (FIMEA), Finland
Business Environment Patient’s View Jan Oliver Huber, General Secretary, Austrian Pharmaceutical Industry Alastair Kent, Genetic Alliance, UK Association (PHARMIG) The Industry’s View Panel discussion with Dagmar Doby, Medical Director Lilly Austria, President Eduardo Bravo, CEO, Tigenix, Belgium Austrian Society Pharmaceutical Medicine Q&A Discussion 10 AWARD WINNERS DIA Award Winners The DIA Awards Ceremony at the 26th Annual EuroMeeting will take place at the beginning of the Opening Reception on Tuesday, 25 March 2014 at the DIA Booth in the exhibition hall. The reception commences at 17:30. Please join us in recognising the contributions of our European award winners.
Founders’ Service Award Outstanding Service Award
Dr Klaus Olejniczak Dr Jorgen Seldrup Non-clinical Regulatory Consultant, Germany Owner, jstatconsult, France
After more than 42 years in the business, in the pharmaceutical industry (UK), Klaus Olejniczak is a graduate in Veterinary Medicine of the Free University in in CROs (UK and France) and in public health (Singapore), Jorgen retired from Berlin. Since 1983, he has been working as a Scientific Director in the German Quintiles in mid-2012 only to set up his own consulting company, jStatConsult. Federal Institute for Drugs and Medical Devices (BfArM), and he was head for Trained as a statistician at Aarhus University, Denmark, he has devoted much of his the Geno – and Reproductive Toxicity Unit until December 2010. professional life to ensure that future statisticians may experience the same rich and enjoyable life as he has. Since 1988, he has been a member of several expert groups, e.g. CHMP Safety Working Party (SWP) and Paediatric Expert Group, representing SWP and has He created PSI, Statisticians in the Pharmaceutical Industry, in 1977, became their been actively involved in the International Conference on Harmonisation (ICH), first Chairman and 10 years later received honorable membership. He has been where he acted as the EU topic leader for several guidelines. President of the International Society for Clinical Biostatistics which bestowed honorable membership upon him in 2007 and he has contributed to the wellbeing Currently he acts as consultant advising companies on non-clinical issues. of several other organizations including the DIA where he stated ‘life’ in 1993 as Chair of the 4th European Workshop on Statistical Methodology in Clinical R & D. Klaus has been actively involved in the DIA since 1988 as speaker, session chair, track chair and programme committee member. He was a member of the DIA Since then he has been Co-Chair of the Workshop on the CPMP Biostatistics Advisory Council Europe. He acts actively in the DIA training course on non- Guideline (1993), Session Chair of the 6th European Workshop on Statistical clinical safety sciences and their regulatory aspects. Methodology in Clinical R & D (1995), Chair of European Statistics Advisory Committee (1997 - 2000), Session Chair & Co-Chair of Track VI at the EuroMeeting (1998), Session Chair of Statistical Methodology in Non-Clinical R & D (1998), Outstanding Service Award Session Chair of the Statistics Track at the Annual Meeting (2000 and 2006).
He has been a member of the European Statistics Community (previously SIAC) Trine Moulvad since 2004 (and Chair 2010-2013) during which time he was an invited speaker Vice President, Novo Nordisk A&S, Denmark at the Plenary Session debate at the Clinical Forum (2009), on the Programme Committee of the 1st Joint DIA/EMA Workshop on Statistics in Clinical R&D (2010), Session organizer and Chair at the 23rd Annual EuroMeeting (2011) and Joint Trine Moulvad is Corporate Vice President at Novo Nordisk Regulatory Affairs Chair of Theme 7: Statistics in drug development at the 24th Annual EuroMeeting in Denmark and has more than 20 years all-round international regulatory (2012). He has been a member of Advisory Council for Europe since 2011. experience from the pharmaceutical industry having lived and worked in both the UK and the US. Trine has specialised within the clinical regulatory area His main consulting interests are: Regulatory statistical strategic advice on drug and drug development and worked within several therapeutic areas: fertility, development plans as well as individual protocols/trials including client support at obstetrics, urology, oncology, CNS, diabetes, obesity and haemostasis – always FDA/EMA meetings, Data Monitoring Committees/Data Safety Monitoring Boards with a particular interest in regulatory project management, strategic thinking and Due Diligence. and the ‘label as the driver’.
Trine has broad knowledge from other drug development areas outside of Regulatory Affairs such as Pharmacovigilance and Clinical Operations. She has Outstanding Service Award negotiated extensively with Regulatory Agencies worldwide and has a keen interest in this particular aspect of the work of Regulatory Professionals. Nikos Dedes European Aids Treatment Group, Belgium Trine has during her career always been externally involved incl. course and conference leaderships and lecturing on an ongoing basis and is a longstanding member of DIA, since 2010 a member of the Advisory Council for Europe Nikos Dedes is Founder and Chair of ‘Positive Voice’, the Greek Association (ACE). Most recently Trine headed up an ACE task force that provided the of People Living with HIV and Founder and Vice-Chair of ‘Prometheus’, the DIA Europe office with an overview of previous and ongoing initiatives and Hellenic Liver Patient Association. He is a past Chair of the European AIDS recommendations on where ACE should focus going forward. Further she has Treatment Group (EATG). been DIA Euro meeting session chair and co-chaired the Regulatory ‘track’ of the Euro meeting 2012. Currently he is a member of the Management Board of EMA, a member of the Steering Committee of the European HIV Clinical Trials Network, a member of the HIV Treatment Guidelines Panel of the European AIDS Clinical Society, a member of the Strategic and Technical Advisory Committee for HIV/AIDS at WHO and a member of various advisory boards for DG Research projects and at the ECDC.
Nikos has been participating at DIA activities since 2005, is a member of the DIA Advisory Council of Europe (ACE) and was Theme Leader of ‘Media, Society and Research’ at the Berlin 2009 EuroMeeting. 2014-2015
DIA EUROPE MIDDLE EAST & AFRICA CONFERENCES & WORKSHOPS
DIA/EFPIA Information Day on ICH 28 March 2014 | Vienna, Austria | ID 14114 About DIA 7th European Conference on Rare Diseases & Orphan Products and Exhibition 8-10 May 2014 I Berlin, Germany | ID 14106 | www.rare-diseases.eu DIA is the global connector in the 8th European Forum for Qualified Person for Pharmacovigilance (QPPV) life sciences product development 13-15 May 2014 | London, United Kingdom | ID 14104 process. Our association of more than Achieving Improved Regulatory Efficiency within the current Framework: 18,000 members builds productive Lessons from the Escher Project – jointly organised by DIA and TOPRA relationships by bringing together Mid-September 2014 | Brussels, Belgium regulators, innovators, and influencers 8th Annual European Medical Information and Communication Conference and Exhibition to exchange knowledge and collaborate 23-24 September 2014 | London, United Kingdom | ID 14103 in an impartial setting. DIA’s network Clinical Trials Workshop I − Translating the New Clinical Trials Regulation into Practice 23-24 September 2014 | London, United Kingdom | ID 14111 creates unparalleled opportunities for exchange of knowledge and has the Clinical Trials Workshop II − Translating the New Transparency Requirements into Practice 24-25 September 2014 | London, United Kingdom | ID 14116 inter-disciplinary experience to prepare for future developments. Joint DIA/FIP European Workshop Biorelevant Performance Testing of Orally Adminitered Dosage Forms 24-25 September 2014 | Amsterdam, the Netherlands The dedicated efforts of DIA staff, EFGCP/DIA/EMA Annual Conference on Better Medicines for Children – Exploring ways to enhance collaboration members and speakers enable DIA to between key players 30 September – 1 October 2014, EMA Headquarters, London, United Kingdom provide a comprehensive catalogue of conferences, workshops, training Joint DIA/ICOS Conference on Cardiac Toxicity Resulting From Cancer Chemotherapy: Strategies for Early Detection, Risk Mitigation and Clinical Prevention and Exhibition courses, scientific publications and 9-10 October 2014 | Prague, Czech Republic | ID14108 educational materials. DIA is a global 4th African Regulatory Conference and Exhibition community representing thousands of 22-23 October 2014 | Dakar, Senegal | ID 14105 stakeholders working together to bring Workshop on HTA and Access to Medicines Status and Future safe and effective products to patients. End October 2014 | location to be confirmed
ISPE/DIA Workshop on Computer Science Compliance “Maintain Data Integrity to Reduce Risk DIA is an independent, non-profit for the Patient” organisation headquartered in 6-7 November 2014 | Basel, Switzerland | ID 14112 Washington, DC, USA with the Joint DIA/AEMPS Statistics Workshop European office in Basel, Switzerland, 10-11 November 2014 | Barcelona, Spain | ID 14107 and additional regional offices in MAGHREB Regulatory Conference and Exhibition Horsham, Pennsylvania, USA; Tokyo, November 2014 | Algiers, Algeria | ID 14113 Japan; Mumbai, India; and Beijing, 15th Conference on European Electronic Document Management (eDM) and Exhibition China. 1-3 December 2014 | Berlin, Germany | ID 14110
Biosimilars Conference For more information, visit 2-3 December 2014 | Berlin, Germany | ID 14115 www.diahome.org or 8th Annual Clinical Forum and Exhibition call DIA Europe +41 61 225 51 51 14-15 April 2015 | Paris, France | ID 15103
27th Annual EuroMeeting and Exhibition 13-15 April 2015 | Paris, France | ID 15101
For more information please contact: DIA Customer Services Team DIA Europe Tel: +41 61 225 51 51 or Küchengasse 16 email: [email protected] 4051 Basel website: www.diaeurope.org Switzerland November 2013 12 PROFESSIONAL POSTERS | STUDENT POSTERS
Professional Poster Authors P13 Ludivine Pennaneach, Solution Specialist, Thomson Reuters, France 30 Years of the Hatch Waxman Act of 1984: Will three decades of A selected group of professional poster presenters will share their research growth in small molecule generics be followed by biosimilars? results in various topics. P14 Richard Preston, Professor Clinical Medicine, Director, Clinical Visit the Exhibition Hall to view the Professional Posters. Pharmacology Research, University of Miami, USA Effects of Nebivolol versus Metoprolol on Sodium Sensitivity and P1 Amer Alanazi, Assistant Professor of Pharmaceutical Biotechnology, Renal Sodium Handling in Hypertensive Postmenopausal Women King Saud University, Saudi Arabia Antifungal efficacy of Amphotericin B loaded plasma beads in P15 Badri Rengarajan, Senior Medical Director, Evidera, USA treatment of Cryptococcus neoformans infection in mice Using Virtual Population Simulation to Identify Possible Areas of Cardiovascular Safety Concern P2 Romuald Braun, e-consulting, Uanotau Ltd, Switzerland Selection of an EDMS/RIM/QMS solution considering on-premises P16 Hege Roenning, Managing Director Norway, Lindeq, Norway and off-premises approach Reporting of serious undesirable effects (SUEs) in compliance with Regulation No 1223/2009 P3 Zsuzsanna Csutor, Director of Pharmacovigilance Services, B&C Consulting, Switzerland P17 Mikhail Samsonov, Chief Medical Officer, R-Pharm, Russian The Silver Lining of the Psmf - Flow Chart Displaying Business and Federation user requirements Use of web based automated workflows in pharmaceutical industry
P4 Melissa Esteban Soto, Cornelius Schep, Safety Science Leader, F P18 Thomas Schindler, Head Medical Writing, Boehringer Ingelheim Hoffman-La Roche, Switzerland Pharma GmbH., Germany Merging three aggregate safety reports into one Integrated Drug What represents good quality in a clinical study report? Safety Master File P19 Soumick Sikdar, Senior Safety Scientist, Amal Sottou, Safety P5 Brian Godman, Senior Researcher, Karolinska Institute, Sweden Physician, United Biosource Corporation (UBC), UK Essential to have new models to optimise the managed entry of new The current challenges in dealing with adverse event reports from drugs in Europe social media
P6 Anna Kubik, Regulatory Manager, KCR.S.A, Poland P20 Ernst Singer, Professor of Pharmacology, Chairman Ethics Registration of clinical trials in Serbia and Ukraine – submissions to Committee of the Medical University of Vienna, Austria CA and EC one day before European Union ECS - an open-source software solution satisfying all requirements of an EC office. The Vienna Experience P7 Sasha Lauks, Analyst, Quintiles Consulting, Inc, UK The effect of Patient Reported Outcomes on Health Technology P21 Tina Wang, Portfolio Manager HTA Programme, CIRS Centre for Assessment recommendations in Oncology in France, Germany and Innovation in Regulatory Science, UK UK Availability of New Medicines – Characterising the factors influencing drug roll out to six mature markets P8 Michael Marx, Associate Medical Director, Icon Clinical Research, Germany P22 Bernd Westhof, Senior Director Benefit Risk Management, Quintiles Improvement of 24/7 Medical Emergency Coverage for both regional Gmbh., Germany and global studies by using a single, global approach A strategic approach to portfolio Benefit Risk Assessments (BRAs)
P9 Deirdre McCarthy, Director, Integrated Post-Marketing and QPPV P23 Manabu Yamamoto, Clinical Research Division, Japan Medical Services, Customer Safety Services, Quintiles Ireland, Ireland Association Centre for Clinical Trials, Japan Advances in the understanding of depression and the safety profile Investigator-Initiated Clinical Trials Outcomes and actions taken by of novel therapeutic strategies JMACCT
P10 Toshinori Murayama, Deputy Director and Associate Professor, P24 Alexis Pincon, Managing Director, Nour Zibian, Safety Scientist, Kyoto University Hospital, Japan United Biosource Corporation (UBC), Switzerland Kyoto University Hospital Institute for Advancement of Clinical and A signal management adaptative model Translational Science (iACT), aiming at a worldwide ARO
P11 Darshan Patel, Associate Director Regulatory Affairs, Sunovion Student Poster Authors Pharmaceuticals Inc., USA Poster Committee Comparison of Clinical Trial Application Approval Rates for Global, Angelika Joos, Head of Regulatory Policy EU and Most of World, Merck Sharp Placebo-Controlled Versus Comparator-Controlled Studies and Dohme, Belgium Birka Lehman, Director and Professor, Head of EU and International Affairs, P12 Krista Payne, Executive Director and Principal Scientific Consultant, BfArM, Germany Dara Stein, Senior Research Scientist United Biosource Corporation Carl Naraynassamy, Director, Explicator, Ltd, UK (UBC), Canada Klaus Olejniczak, Non-clinical Regulatory Consultant, Germany Retrospective chart review studies and safety reporting requirements: issues and considerations Student abstracts selected by the review committee, addressing similar topics to those in the programme, will be on display on the exhibition floor. Presenters will be able to discuss their work during the coffee and lunch STUDENT POSTERS | FELLOWSHIPS 13 breaks on Wednesday, 26 March, 2014. An awards ceremony will be held on DIA Student Fellowship Programme Wednesday, 26 March 2014 at 17:45 at the DIA Booth in the exhibition hall to award the first, second and third-place student poster winners. The Drug Information Association in Europe promotes the participation of students in the annual EuroMeeting by offering up to 20 complimentary SP1 Ana Begic, Faculty of Pharmacy and Biochemistry, University of registrations for full time students. Zagreb, Croatia Biomedical Potential of Stevia - Stevia rebaudiana (Bert.) Bertoni • Josip Barilar, University of Zagreb, Croatia SP2 Charlotte Benoit, Samer Bounni, Université Claude Bernard Lyon 1, • Jessica Bonnefoy, Claude Bernard University Lyon1, France France • Samer Bounni, Claude Bernard University Lyon1, France ACE-inhibitors for the prevention of sudden cardiac death: • Sabina Burla, University of Medicine and Pharmacy Iuliu Hatieganu, a meta-analysis of randomised controlled trials Romania • William Wei Lim Chin, European Centre for Regulatory Affairs Freiburg/ SP3 Pauline Blanchard, Vanessa Ville, Claude Bernard University, France University of Strasbourg, Germany Incidence of hypersensitivity reactions (HSR) to oxaliplatin (OP), • Tina Dannemann Purnat, University of Munich (LMU), Germany identification and meta-analysis of potential risk factors. • Gwenaelle Denis, Universite Claude Bernard Lyon 1, France • Patrick Gassenbauer, University of Vienna, Austria SP4 Jessica Bonnefoy Isabelle Delfour, Gwenaelle Denis, Eudipharm, France • Patricia Marić, Faculty of Pharmacy and Biochemistry, University of Designs for Phase I clinical trials in paediatrics. Comparison of Zagreb, Croatia methodologies to determine the efficacious dose • Oana Oprea, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Romania, Romania SP5 Katarina Iric, Faculty of Pharmacy, Serbia • Karolina Paciorek, Medical University of Warsaw, Poland Testing the impact of modified reformatsky reaction on the synthesis • Eleni Papadatou, Comenius University, Slovakia of 3,3-bis-(4-chlorophenyl)-3-hydroxypropionic acid • Lucile Penaud, Universite Claude Bernard Lyon 1, France • Rui Saldanha, University of Lisbon, Portugal SP6 Monica Luca, University of Medicine and Pharmacy Carol Davila • Irlene Shen, University of York, UK Bucharest, Romania • Fabio Silva, University of Lisbon, Portugal Evaluation of the non-clinical action of alpha-lipoic acid on • Gabriela Valentová, European Pharmaceutical Students Association Vincristine- and Paclitaxel-induced neuropathic pain (EPSA), Belgium SP7 Alexia Malriq, Hospices Civil De Lyon, University of Lyon, France, • Andre Vila Nova, University of Lisbon, Portugal Clinical Trial Data Sharing: Public access to clinical trials data on • Vanessa Ville, Claude Bernard Lyon 1, France medicinal products is coming soon • Jakub Weber, Charles University in Prague, Czech Republic • Stavroula Zagkou, Comenius University, Slovakia SP8 Florence Margraff, Hospices Civil De Lyon, University of Lyon, France. Adverse drug reaction reporting by patients in fifty countries DIA Young Professional SP9 Monika Mironiuk, Medical University of Gdansk, Poland. Fellowship Programme Plasma non-targeted metabolic fingerprinting as a potential prognostic tool for drug-resistant hypertension DIA welcomes the involvement of young professionals in the EuroMeeting. The following young professionals received a young professional fellowship SP10 Julie Mouchet, Lucile Penaud, Baptiste Maeseele, Université Claude for the EuroMeeting 2014: Bernard Lyon I, France Is there a publication bias for studies assessing the benefit of fatty • Pablo Amaya, Merck Sharp & Dohme Europe Inc., Belgium acids in attention deficit hyperactivity disorder? • Gizem Ruya Camca, Polifarma Ilac, Turkey • George Collins, Medicines and Healthcare Products Regulatory Agency SP11 Isabelle Rodrigues, University of Lisbon, Portugal (MHRA), UK Ibuprofen promotes age-related bradikinin but not the acethylcholine - induced rat ileal contractility • Dorota Distlerová, State Institute for Drug Control, Slovakia • Pedro Gomes, European PharmInvent, Czech Republic SP12 Maidah Sheikh, University of Vienna, Austria • Vladimir Ivanovic, Bayer HealthCare, Serbia The organic anion transporting polypeptide OATP4A1 may be a • Ruzica Jagic, Sandoz, Croatia target for immunomodulation in early colorectal cancer • Camilla Lavoll, Novartis Norge AS, Norway • Barbora Malinová, RM PHARMTRADE, Czech Republic SP13 Indre Šveikauskaite, Lithuanian University of Health Sciences, • Anne-Laure Pomaret, Bayer HealthCare, France Lithuania • Martina Vlkova, Pharminvent, Czech Republic Differences of lead and nickel ions effects on total protein and • Martje Wijtenburg, DADA Consultancy, the Netherlands metallothioneins synthesis in mice liver
SP14 Birce Didar Tut, Istanbul University, Turkey, Assessment of risk management approaches in orphan drugs 14 FELLOWSHIPS
PATIENT Fellowship Programme Members Lounge The Patient Fellowship, now in its ninth year, is a programme to promote the V.I.P. Feeling for DIA Members participation of representatives of patients’ organisations in the EuroMeeting. Each year, DIA supports patients’ representatives and speakers to attend the DIA Members can relax in the Members-only Lounge in the Exhibition Hall EuroMeeting by either offering full support or a registration fee waiver. The during breaks, or whenever a few minutes in a quiet setting is needed. Coffee and drinks are served throughout exhibition opening hours and patients’ representatives whom the DIA supported to attend the EuroMeeting charging stations for your electronic devices are available. Make sure you in 2014 are: bring your new membership card to identify yourself as a DIA Member at the desk. Access exclusively for DIA Members. • Mary Baker, European Brain Council, UK • Lara Bloom, Ehlers-Danlos Support UK, UK Note: if you have not yet received your new membership card, have it • Stephanie Clark, ADHD-Europe, Belgium printed onsite at the DIA Booth. • Viorica Cursaru, Myeloma Euronet, Romania • Mihaela Despa, Myeloma Euronet, Romania • Isabel Fernandez Aldeguer, Spanish Federation of Rare Diseases (FEDER), Spain • Jan Geissler , EUPATI, Belgium • Marco Greco, European Patients Forum, Belgium • David Haerry, European AIDS Treatment Group (EATG), Switzerland • Anne Hugon, French Glycogen Storage Disease (AFG), France • Julian Isla, Dravet Syndrome Foundation Europe, Spain • Chris James, Motor Neurone Disease Association, UK • Sabine Karner, Österreichische Kinder-Krebs-Hilfe, Austria • Alastair Kent, Genetic Alliance UK • Olesandr Korenkov, Ukrainain Union of Patients Organizations, Ukraine • Inna Krulko, Ukrainian Union of Patients Organizations (UUPO), Ukraine • Yann Le Cam, EURORDIS, France • Vitaliy Matyushenko, Charitable Foundation "Children With Spinal Muscular Atrophy", Ukraine • Maria Mavris, EURORDIS, France • Luybomir Naydenov, Bulgarian Society of Patients with Pulmonary Hypertension, Bulgaria • Gerard Nguyen, Hôpital Avicenne Aphp/Rett Syndrome Europe, France Clinical Trials Workshop I −Translating • Valentyna Ocheretenko, Ukrainian Union of Patients Organizations the New Clinical Trial Regulation into (UUPO), Ukraine Practice • Kay Parkinson, Alstrom Syndrome UK, UK • Rob Pleticha, EURORDIS, France • Tsveta Schyns-Liharska, European Network for Research on Alternating Hemiplegia (ENRAH), Austria Event #14111 • Christos Sotirelis, United Kingdom Thalassaemia Society, UK 23-24 September 2014 • Tugce Suyabatmaz, Pembe Hanim NGO, Turkey Millennium Gloucester Hotel London Kensington, UK • Christoph Thalheim, European Multiple Sclerosis Platform (EMSP), Belgium • Cengiz Unutmaz, To Pink and To Life, Turkey • Nadja Uzunovic, PORT - NGO helping cancer patients in Bosnia and Herzegovina, Bosnia and Herzegovina • Martin van Schijndel, Dutch Parkinson Association, The Netherlands • Gábor Varga, Hungarian Haemophilia Society, Hungary • Ariane Weinman, EURORDIS, France • Dieter Wenzel, MPN-Netzwerk e.V, Germany • Durhane Wong-Rieger, International Alliance of Patients' Organization (IAPO), Canada
Patient Networking Lunch Tuesday, 25 March 2014 | 12:45-13:45 | Lounge 7/8 Level O1 Patient Representatives and Patient Speakers only
Facilitator: Maria Mavris, Therapeutic Development Director, EURORDIS, France
Overview of the EuroMeeting Scientific programme and an opportunity for Patient Representatives to meet and network with each other prior to the conference. 15
Welcome to DIA Communities
Reaching around the world to create a global community!
Meet colleagues who share your professional interests, share experience and knowledge
GET INVOLVED DIA Booth 504 | Tuesday, 25 March, 12:00 – Thursday, 27 March, 16:00 Pick up your community ribbons, view a demonstration of the global community communications tool ConneX, and find out how to get more involved in DIA and what’s in it for you:
• 35 communities exclusively for DIA members • Network with specialists you wouldn’t normally meet • Keep your finger on the pulse of hot topics and shared learning • Easier access to speaking opportunities
MEET THE VOLUNTEERS Key DIA Volunteers and Community Leaders are ready to meet and share their experiences with you at the DIA Booth during conference refreshment and lunch breaks. While finding out about upcoming DIA events and learning about new European Membership benefits, use the opportunity to talk to the experts. Hear first-hand what volunteering did for them – and what it can do for you!
DIA COMMUNITIES MEET AND EAT Exhibition Hall Y | Wednesday, 26 March | 12:30 – 13:15 The Community Leadership Council Co-Chair Gesine Bejeuhr welcomes you to meet and eat with selected Community leaders. Feel free to walk in and join us spontaneously – old and new members are welcome alike.
Speakers Corner with Open Microphone The Meet and Eat gathering features a Speakers’ Corner with an open microphone, a talking point to share best practices and recent developments. Voice your ideas or pose questions, have your say, or sit back and hear what else is going on in the World of DIA Communities.
SPEED NETWORKING Exhibition Hall Y | Tuesday, 25 March, 13:00 – 13:30 | Wednesday, 26 March, 13:30 – 14:00 • Get to know at least six new professionals in twenty minutes and have a laugh! • Limited number of places, first-come, first-served 16 pre-conference TUTORIALS Pre-Conference Tutorials TUESDAY, 25 MARCH 2014 | 09:00 - 12:30
Tutorial 1 | Room G - Level U2 Learning Objectives At the conclusion of this tutorial, participants will be able to: INTRODUCTION TO EU PHARMACEUTICAL LAW AND CURRENT • Share knowledge about the new pharmacovigilance legislation, overall DEVELOPMENTS achievements and lessons learned John Lisman, Lawyer, Lisman Legal Life Sciences, the Netherlands • Discuss key areas of the new pharmacovigilance legislation and further Paul Van Dongen, Lawyer, NautaDutilh, Netherlands developments • Understand the preparation for the implementation of the new ISO Pharmaceutical law is at the base of daily business in the sector. In the last few ICSR/ICH E2B(R3) and IDMP standards with main focus on EU specific years many developments have occurred in the field of pharmaceutical law as requirements well as in the marketing authorisation practice. This tutorial gives you a general • Discuss recent changes and frequently asked questions in relation to GVP introduction to the legal framework, and it brings you up to date in respect module VI of recent and ongoing changes, e.g.: Marketing Authorisation for Biosimilars - Paediatric Regulation - Advanced Therapy Medicinal Products Regulation - Target Audience Pharmaceutical Package: Pharmacovigilance legislation; Directive on Falsified Qualified Persons for Pharmacovigilance (QPPVs) and persons involved in: Medicines; proposed legislation on information to patients - New Guidelines • Pharmacovigilance and Notes for Guidance - Revision of Clinical Trials Legislation. For each of the • Clinical Development topics the most relevant highlights will be presented in an interactive manner. • Information Management • Safety databases Learning Objectives At the conclusion of this tutorial, attendees will be able to: Tutorial 3 | Room 3 - Level O2 • Understand the basics of the legal framework of pharmaceutical legislation in Europe PRACTICAL TOOLS FOR SIGNAL MANAGEMENT SYSTEMS: HOW DO • Explain the changes in the legal framework of pharmaceutical legislation in YOU OVERCOME CHALLENGES AND MEET THE NEEDS OF THE NEW their companies PHARMACOVIGILANCE LEGISLATION? IS DATA QUALITY IMPORTANT? • Participate in an interactive way at the the DIA Euromeeting sessions Morell David, Consultant in Clinical Toxicology and Drug Safety, NDA Group, dealing with new legislation, e.g. clinical trials legislation and the falsified UK medicines directive. Participants should be able to recognise recent case law of the Court of Justice and the General Court. The tutorial will discuss sources of signals from clinical trials to any post authorisation data such as world-wide literature, spontaneous data, post- Target Audience authorisation safety studies, periodic benefit/risk evaluation reports (PBRER), • Non-lawyers who work in a legal environment from industry, government variations, data from other regulatory bodies such as WHO, EudraVigilance agencies and competent authorities and US FDA AERs. The advantages and disadvantages of methodologies used • Lawyers from industry, government agencies and competent authorities who in signal detection and whether data mining tools really help? How analysis have recently started in this position and prioritisation could be carried out and tools which are helpful. We will also consider the impact of communicating these potential safety signals. Finally Tutorial 2 | Room H - Level U2 we will look at database requirements which ensure data quality and minimise the generation of false signals focusing on solutions for large, medium and IMPLEMENTATION OF THE PHARMACOVIGILANCE LEGISLATION IN THE EU small enterprises. - ACHIEVEMENTS, LESSONS LEARNED AND NEXT STEPS Sabine Brosch, Business Lead EudraVigilance and International Standardisation Learning Objectives in Pharmacovigilance and Risk Management Sector, European Medicines At the conclusion of this tutorial, attendees will be able to: Agency, EU • Examine the relationship between data quality and signal detection process Gaby Danan, Hepatologist, Pharmacovigilance Expert, France • Discover the rationale for introducing automated signal detection • Learn about pitfalls in manual signal management systems and best Specific topics will be elaborated on with main focus on Good Pharmacovigilance practices for recording and reporting outcomes Practices (GVP) module VI, the implementation of the new ISO ICSR/ICH E2B(R3) standard as well as coding and data retrieval principles in relation to medication Target Audience errors. In addition, an update will be provided on the latest development on the • Pharmacovigilance professionals business process for notifications of market cessations and medicinal product • Statisticians withdrawals. • QPPVs and deputy QPPVs • Medical Affairs professionals This tutorial will provide a forum for stakeholders to obtain an overview of the • Clinical safety professionals overall achievements and lessons learned regarding the implementation of the new pharmacovigilance legislation. pre-conference TUTORIALS 17 Pre-Conference Tutorials TUESDAY, 25 MARCH 2014 | 09:00 - 12:30
Tutorial 4 | Room N - Level O1 Tutorial 6 | Room O - Level O1
ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS BIOSIMILAR DEVELOPMENT - WHAT ARE THE CURRENT CHALLENGES? Joachim Vollmar, International Clinical Development Consultants, LLC, USA Primal Kaur, Global Development Director, Amgen, USA Jürgen Kübler, Global Head, Clinical Design, Analysis and Reporting, CSL Behring AG, Germany This interactive tutorial will provide an overview of the key steps required for developing a biosimilar, the differences between biosimilars and non This tutorial is a combination of theory, guidelines, practical considerations, and comparable biologics and worldwide guidelines for and regulation of real-life solutions for those working in the clinical development environment biosimilars. It will provide an in-depth understanding of the key principles for (pharmaceutical, biotech industry, or CRO). The aim of this tutorial is to evaluating biosimilars, and give examples that highlight the importance of provide a basic understanding of the underlying methodology and the current clinical trials for detecting clinically meaningful differences. The tutorial will guidelines on safety data. Aspects of the planning of clinical trials as well as explain the need for a separate biosimilars’ pathway to the generics pathway the problems and pitfalls during the analysis of safety data will be presented. as well as the importance of unique naming for biosimilars. Opportunities for prospective planning of safety analysis at the project level will be discussed. The presentations will also include case studies. Learning Objectives At the conclusion of this tutorial, attendees will be able to: Learning Objectives • Describe the differences between biosimilars and non comparable biologics At the conclusion of this tutorial, participants should be able to: • Describe the key worldwide regulations and guidelines for biosimilars • Examine relevant guidelines and regulatory requirements for clinical trials • Describe the key principles for evaluating biosimilars • Recognise how to contribute to safety analysis plans • Discuss the different risk management needs between biosimilars and • Assess statistical safety analysis and identify pitfalls in safety analysis generics • Recognise the impact of benefit/risk assessment in safety data Target Audience Target Audience Professionals involved in the development of Biosimilars. This tutorial is designed for biostatisticians, medical writers, clinical researchers, drug safety specialists, project managers, and investigators. Tutorial 7 | Room 5A - Level O1
INTRODUCTION TO MEDICAL DEVICES (AND WHAT IS COMING NEXT) Tutorial 5 | Room 6B - Level O1 Sabina Hoekstra-van den Bosch, Senior Manager, Standards & Regulations, NON-CLINICAL SAFETY FOR NON-TOXICOLOGISTS: WHAT IS IMPORTANT Philips Healthcare - Global Quality & Regulatory, the Netherlands FOR YOUR SUBMISSIONS? Erik Vollebregt, Attorney, Axon Lawyers, the Netherlands Klaus Olejniczak, Non-clinical Regulatory Consultant, Germany Gerd Bode, Lecturer, University of Göttingen, Essen, Lyon, Bonn and This tutorial will give a condensed overview of the EU device legislative system Consultant, Germany and the principles and philosophy behind it. It will explain the definition of a medical device and subsequently the delineation between medical devices This tutorial identifies the challenges and solutions for integrating all sources and pharmaceuticals and the provisions on combination products will be of toxicological data involved and helps to understand the non-clinical explained. The characteristics and the organisational structure of the medical development and strategies of drug toxicity or safety assessments. The device sector and the role of the various stakeholders in it will be highlighted. international state of the art of non-clinical evaluation of pharmaceuticals, the It will explain the concept of risk classification of medical devices and the interpretation of toxicological data and the acceptability or unacceptability relationship between risk classification and conformity assessment procedures. of toxicological risks (benefit/risk assessments) for pharmaceuticals will be It will highlight the role of the notified bodies in the system and the main discussed. provisions on clinical evaluation and clinical investigation. It will discuss the headlines of the EU regulation of in-vitro diagnostics, with a focus on the This tutorial should attract everybody who is interested in or responsible differences with the medical device regulation. The theoretical concepts will for non-clinical (toxicological) data. This tutorial does not require specialist be illustrated with practical examples. knowledge in this area. The tutorial will include a look ahead regarding the biggest changes that will be brought about by the revision of the medical device and IVD regulations by Learning Objectives the European Union, based on the stage of the legislative process at the time At the conclusion of this tutorial, attendees will be able to: of the conference. • Recognise the principles, objectives and strategies of non-clinical safety evaluation of pharmaceuticals Learning Objectives • Identify the need of interactive discussion of quality, non-clinical and clinical At the conclusion of this tutorial, attendees will be able to: data in drug development • Understand the main characteristics of the EU Medical Device regulatory • Interest in selection and performing of important non-clinical data for system, including the provisions on risk classification, conformity submission of pharmaceuticals assessment, notified bodies, clinical evaluation and clinical investigation • Understand the delineation between pharmaceutical and medical devices Target Audience Non-specialists in toxicology, regulatory affairs personnel, clinical colleagues, Target Audience project team leaders and members Professionals in the pharmaceutical area (e.g. regulatory affairs, clinical development), who either are involved in the development and marketing of drug device combinations or who would like to obtain a condensed overview of the EU medical device regulatory system. 18 pre-conference TUTORIALS Pre-Conference Tutorials TUESDAY, 25 MARCH 2014 | 09:00 - 12:30
Tutorial 8 | Lounge 1 - Level O1 Tutorial 10 | Lounge 6 - Level O1
THE PAEDIATRIC REGULATION STEP BY STEP - FROM THE PIP TO THE HTA: DIFFERENT CONCEPTS FOR DIFFERENT IMPACT ON INNOVATION REWARD AND PATIENT ACCESS Daniel Brasseur, Immediate Past PDCO Chairman, General Directorate Edith Frenoy, EFPIA, Belgium Medicine, Federal Ministry of Public Health (AFMPS), Belgium Geneviève Michaux, of Counsel, Hunton & Williams, Belgium Publicly funded healthcare systems in European countries base their decisions on access to medicines on evidences and Health Technology Assessment The tutorial analyses each relevant step of the Paediatric Regulation, from the (HTA) is used to prepare and present this evidence. But HTA means different PIP to the reward. It teaches the participants (i) to assess whether a PIP is things in different countries, and HTA processes, methodologies and impact on needed and, if so, to prepare a PIP proposal which is consistent with the EMA’s decisions differ. We will outline market access processes for medicines in BE, new policies, (ii) to best use the paediatric procedures to secure acceptable FR, DE, IT, NL, PL, SE, England/Wales and also the US, to identify where HTA paediatric studies, (iii) to determine the impact of the paediatric requirements fits in these systems and what type of HTA is used. We will describe in detail on the (successive) regulatory approval(s) of the product, and (iv) to predict the types of HTA used in FR, DE, England/Wales, PL, and the type of evidence the eligibility for the reward(s) and the steps to undertake to secure their requested from manufacturers across the medicines' life-cycle. We will describe granting. the differences between regulatory requirements and HTA clinical evidence requirements, and economic evaluation requirements. In practical exercises, Learning Objectives participants will get a better understanding of the underlying assumptions At the conclusion of this tutorial, attendees will be able to: behind HTA requirements. Based on this review and on participants' knowledge • Analyse each relevant aspect of the Paediatric Regulation and their of development, regulatory and market access processes, we will discuss how interactions regulatory assessment and HTA could be streamlined, and which assessment • Assess how the Paediatric Regulation will or may affect the development of elements could be shared between countries. We will compare these findings their products with current policy discussions in Europe. • Adapt development plans accordingly and to anticipate possible issues Learning Objectives Target Audience At the conclusion of this tutorial, attendees will be able to: Professionals in the pharmaceutical area involved in regulatory, legal and • Identify the differences and similarities in objectives, procedures and clinical research. methodologies of existing HTA systems • Manage internal company processes to optimally contribute to HTA Tutorial 9 | Room 6A - Level O1 submissions early in the process • Influence internal and external policy discussions on regulatory-HTA EARLY ACCESS SCHEMES: CONSIDERATIONS FOR DEVELOPING interactions and on European collaboration on HTA with their specific REGULATORY STRATEGIES knowledge and experience Sharon Gorman, Director EU Regulatory Policy and member of EBE Regulatory and Technical Affairs Committee, Pfizer Ltd., UK Target Audience Kate Beaujeux, Senior Director European Regulatory Affairs and Chairperson • Medical affairs, regulatory and all other industry experts who want to of the EBE Regulatory and Technical Affairs Committee, Medimmune, UK understand why their market access colleagues ask them for additional
evidence for 'HTA'; and market access experts who want to hear their Patients are waiting to obtain access to novel medicines. Regulatory colleagues' point of view. processes exist that may aid faster access for patients. However, not every • Representatives from regulatory and HTA authorities who are asked to align approach is applicable for all circumstances. Additionally, other approaches their pre- and post-approval evidence requirements. are being developed such as Adaptive Licensing that could help to speed the development process while maintaining the robust assessment of benefits and Tutorial 11 | Room 4 - Level O2 risk. Strategic considerations need to be taken into account when determining which approach to follow. The different processes will be outlined and, using HOW TO REGISTER COMBINATION PRODUCTS AND COMPANION DIAG- different situations, participants will discuss the most important strategic NOSTICS: REGULATORY FRAMEWORK AND STRATEGIES FOR A SUCCESS- aspects before embarking on a particular pathway and the future impact of FUL DEVELOPMENT proposed new pathways. Magali Gibou, Senior Regulatory Affairs Manager, Transgene, France Tina Amini, Pharmaceutical Expert, Device/Drug Combination Products, BSI Learning Objectives Group, UK At the conclusion of this tutorial, attendees will be able to: • Distinguish and compare the options available for faster regulatory approval This tutorial will give a condensed overview of the medical device and in- in the major global regions vitro diagnostics legislative systems, including the classification rules, the • Assess the merits of each option to evaluate the best strategic course of requirements for clinical investigations and the role of competent authorities action and notified bodies at the development stage and for the conformity assessment. It will describe the current regulations with a focus on the Target Audience differences with the coming new regulations on medical devices and in vitro Medical affairs, regulatory and all other industry experts who want to diagnostics that are currently discussed at the European parliament. It will understand how different regulatory approaches can help contribute to highlight potential challenges of the co-development of drug/medical device getting innovative medicines to patients faster. and drug/companion diagnostic products, illustrated with practical examples. Finally, some example of successful co-developments will be summarised with a focus on recently marketed drug/companion diagnostic products. pre-conference TUTORIALS 19 Pre-Conference Tutorials TUESDAY, 25 MARCH 2014 | 09:00 - 12:30
Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Understand the coming regulatory framework for drug/medical devices and Always Stay drug/IVDs registration One Move Ahead • Estimate how the changes in the forthcoming regulations will impact current development projects in your company with DIA Europe • Implement good development practices in favour of a successful combination Training Courses product/companion diagnostics development
Target Audience Professionals in the pharmaceutical area (regulatory affairs, clinical The Best Value Training development) who are involved in the development and marketing of drug/ medical device combinations or drug/companion diagnostics. Available Anywhere
Tutorial 13 | Room 2 - Level O2 First-rate instructors and best-in-class content are what make DIA Europe’s AN INSIDER'S LOOK AT THE EMA: COMMITTEE INTERACTION training programmes the highest quality training programmes available Anthony Humphreys, Head of Committee Secretariat Department, European anywhere. DIA Europe offers a variety of courses in regulatory affairs, Medicines Agency, EU clinical research, non-clinical safety sciences, pharmacovigilance and CMC, e.g. on Quality by Design. Since the foundation of EMA with two principal scientific committees (CVMP / Advantages include: CHMP), the number of scientific committees has increased to seven as a result of major legislative initiatives within the European regulatory arena. • Expert instructors actively practising in their particular discipline • Continuing education This tutorial will focus on the main interactions between the various human • Networking opportunities scientific committees as well as significant other bodies i.e. SAWP and CMD(h) • Consistent course materials from one offering to another involved in the product development life cycle. A number of case studies will • Limited attendance allows for a more personal quality learning be presented to illustrate these interactions and how they seek to address experience challenges in the evaluation of innovative medicines, and the emergence of • Tailor-made case studies and instructor-led group work personalised medicines. • In-depth discussion of specific contemporary issues
The tutorial will also address the increasing transparency associated with the operation of the committees and to aid understanding of content released. For more information and a complete listing of all Learning Objectives training courses, please visit www.diahome.org At the conclusion of this tutorial, participants should be able to: and click on Meetings & Training • Understand the key interactions between the scientific committees and how they impact on company's development planning • Understand how personalised medicine is being tackled by the various committees • Interpret publications released regarding the committee operations e.g. DIA Europe Tailored Training agendas/minutes etc.
DIA Europe Tailored Training is a highly flexible, efficient and cost-effective Target Audience way to get the maximum return on your training investment. Schedule your Regulatory affairs professionals, project team leaders/managers, regulatory training course when it suits you best, at the venue of your choice. You can intelligence advisors even adapt the content to include areas specific to your environment, and to match the level of expertise of the audience.
DIA Tailored Training is available to both public and private institutions and is delivered by instructors with no conflict of interest.
The DIA Tailored Training programmes in Europe make the most of a selection of world-class expert faculty who are experienced professionals in the pharmaceutical and related industries.
Contact DIA Europe to discuss your organisation’s requirements. 20 pre-conference TUTORIALS
Pre-Conference Tutorials TUESDAY, 25 MARCH 2014 | 09:00 - 12:30
Young Professional Tutorial STUDENT Tutorial
Room M - Level O1 Room L - Level O1
PLAN YOUR CAREER IN PHARMA OR ASSOCIATED INDUSTRIES THE IMPORTANCE OF EMOTIONAL INTELLIGENCE IN ACHIEVING SUCCESS Sonja Pumplün, Actelion, Vice President Head, Global Drug Regulatory Affairs, AT JOB INTERVIEWS AND IN DEVELOPING YOUR FUTURE CAREER PATH Actelion, Switzerland Judy Churchill, Director, Language Consulting Services, UK Annette Mollet, Head of Education & Training, ECPM Institute of Pharmaceutical Alexandra Marques, Intern, International Pharmaceutical Federation (FIP), Medicine, University of Basel, Switzerland the Netherlands
Speakers: Understand the soft skills that recruiters and pharmaceutical companies Alex Khatuntsev, Human Resources Director, Actelion Pharmaceuticals, require from a job applicant. Learn how to improve or acquire these Emotional Switzerland Intelligence skills. Understand the 'what, why and how' of Emotional João da Silva Duarte, Regulatory Intelligence & Policy Manager, H. Lundbeck, Intelligence (E.I.) in career development and why it is essential for success and France career mobility.
This tutorial will highlight key decisions and planning steps for career paths. Participate in practical hands on Emotional Intelligence exercises. Options and strategies how to find the right career track in the health care The tutorial will be divided into two main chapters containing sub-parts. system will be discussed. Possibilities to enhance your skills and expertise will be presented. Different players in the system will be introduced. Chapter 1 will focus on the soft skills required for job interviews: Part 1. What is your emotional intelligence quotient (EQ)? The tutorial will also focus on the importance of soft skills. An interactive case Part 2. EQ and recruiters. study of soft skills will be presented, examples how to acquire and advance Part 3. Improve your EQ them and how to best apply them, are discussed. Part 4. Frequently asked questions.
Part 1 | Career Path Examples Chapter 2 will examine the importance of E.I. in developing your career. Speakers will discuss their personal career path being in different departments/ Part 1. Why is E.I. so important when working in a company and building a organisations, including smaller companies and large pharmaceutical team? organisations. In their presentation the speakers will outline important Part 2. What do you need to do to maintain and build E.I.? considerations for planning a career as follows: Part 3. How to continually assess your E.I. and improve in the workplace
• Importance of the true understanding of each individual. How to assess your Both chapters will end with practical exercises. strengths? • How to build your career path, considerations to be taken? Target Audience • How to enter and advance in the pharmaceutical industry or associated Students organisations? • How to move between departments and responsibilities as well as companies. How do you get these opportunities (where to look, network etc)? • What to prepare for the interview phase? • Why did they speakers choose a certain way, what motivated them? 4th African • Did size make a difference: which aspects to consider when moving to a small pharmaceutical company or national association? Regulatory Conference • Increase your value by adding new skills or broaden your knowledge • What kind of advanced training opportunities exist? How to choose the right & Exhibition training. • At the end of the presentation there will be a round table discussion with A Forum for Regulatory guidance provided Authorities and the Pharmaceutical Industry Part 2 | The power of Soft Skills Case studies with short introductory presentations as well as an overview of today’s most relevant soft skills are provided. The session will focus on the following questions. 22-23 October 2014 Dakar, Senegal • Which soft skills are most relevant for the different career paths? • How to work in an International, Multicultural environment? • How can these soft skills be strengthened of advanced? • What is available on the internet?
Target Audience Young professionals that are interested in further insights about planning their next career steps and learning more about the importance of soft skills
22 theme 1
Theme 1 | Regulatory Science The Business Need for Changing the R&D Model Nick Sykes, Senior Director, Worldwide Safety and Regulatory, Pfizer, UK Richard Bergström, Director General, European Federation of Pharmaceutical Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Industries and Associations (EFPIA), Belgium Devices Agency, Austria The Role of the 21st Century Regulator Ian Hudson, Chief Executive, MHRA, UK This theme will consider how the regulatory environment should evolve to meet the needs of the future. The individual sessions will facilitate discussions Innovation in Regulation to Support Innovation in Development on the business needs for change, the barriers and challenges (and options Isabelle Clamou, Regulatory Affairs Director – EU Policy, Amgen, Belgium available to overcome them) and the enablers that need to be fostered. Discussion topics include redesigning regulatory approval processes to foster Session 0103 | Wednesday, 26 March, 14:00-15:30 | B-U2 rapid patient access to new medicines and the impact that these may have on the development processes, specific regulatory considerations for novel REGULATORY TOWN HALL MEETING types of products (biosimilars, personalised medicines, advanced therapy Session Co-Chairs: medicinal products), new EU legislation governing medicinal products and the Guido Rasi, Executive Director, European Medicines Agency, EU issues they present, adapting the label for a digital age, and a Town Hall of EU Christa Wirthumer-Hoche, Head, Austrian Medicines and Medical Devices regulators. Agency (AGES), Member CMDh, Austria
Session 0101/0301 | Wednesday, 26 March, 09:00-10:30 | B-O2 At the Town Hall Meeting attendees can put burning questions to expert regulators about these topics: PANEL DISCUSSION: MAKING THE PHARMACOVIGILANCE LEGISLATION WORK – A TEMPERATURE CHECK • Transparency Session Chair: • Implementation of the Pharmacovigilance Legislation Vicki Edwards, QPPV and Head of Affiliate Vigilance Excellence, Global • Latest Changes to the Clinical Trial Legislation Pharmacovigilance, AbbVie Ltd., UK • Innovation - Products in the pipeline • EU-enlargement with Croatia This session will explore experiences and impact to date of the implementation of the new pharmacovigilance legislation from the point of view of multiple June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, stakeholders. The new legislation has had impact across a broad range of MHRA, UK safety related activities, however this session will focus on areas where we Andrzej Rys, Director of Health Systems and Products, European Commission, have seen fundamental changes. The session will be conducted as a panel EU discussion where views from a PRAC member, a Member State Competent Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products Authority, the industry and a patient perspective will be heard. The panel Agency (MPA), Sweden will consider if the objectives of the new legislation are yet being met in Viola Macolic Sarinic, Head of Agency, Agency for Medicinal Products and particular with respect to the need to consider risks in the context of benefit, Medical Devices (HALMED), Croatia the increased focus on management of risk in the post-marketing environment Walter Schwerdtfeger, President, Federal Institute for Drugs and Medical and the role of the Pharmacovigilance Risk Assessment Committee (PRAC). Devices (BfArM), Germany The panel will also discuss their views on the impact of the transparency measures on communication and decision making. Session 0104 | Wednesday, 26 March, 16:00-17:30 | E1-OE
Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), HOW TO GET READY FOR THE NEW CLINICAL TRIALS LEGISLATION the Netherlands Session Chair: Sabine Atzor, Head of EU Regulatory Policies, F. Hoffmann-La Roche, Theo Raynor, Professor of Pharmacy Practice, School of Healthcare, University Switzerland of Leeds, UK June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, The new Clinical Trials Regulation is likely to be adopted in 2014 and will MHRA, UK become applicable two years thereafter. The new legislation is expected to bring significant improvements with a single submission to the EU database, Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer a single (joint) assessment by all concerned member states and a single Pharmaceuticals, Germany decision by each member state within competitive timelines. Member States decide how they organise the work between competent authorities and ethics Maria-Grazia Zurlo, QPPV, Pfizer, UK committees. To gain experience, pilots have been conducted by member states with an coordinated integrated assessment process involving competent Session 0102 | Wednesday, 26 March, 11:00-12:30 | E1-OE authorities and ethics committees through the Voluntary Harmonisation Procedure as “VHP +”. As a trade-off for competitive assessment timelines, HURDLES TO OVERCOME TO ENSURE REGULATORY SUCCESS FOR THE companies are expected to prepare complete submissions so as not to risk the NEXT GENERATION OF PRODUCTS withdrawal of a submission. Session Chair: Susan Forda, Vice President, Global Regulatory Affairs, International, Eli Lilly Update of the Legislative Process & Co., UK Sabine Atzor, Head of EU Regulatory Policies, F. Hoffmann-La Roche, Switzerland One of industry’s key responses to the EU’s Horizon 2020 programme is to initiate a series of work streams to investigate new models for R&D. The aim is Experience by the Member States to ensure that the development and regulatory models of the future meet the Hartmut Krafft, VHP Coordinator, Paul Ehrlich Institute, Germany needs of all stakeholders and continue to get innovative products to patients as quickly as possible. This session will outline the business needs for change Piloting a new model as VHP(+) - Experience from a Company within both industry and at the regulator level and will explore what needs to Surendra Gokhale, Head of EU/ROW CT Regulatory Management, F. Hoffmann- be done to ensure a successful evolution. La Roche, Switzerland THEME 1 23
How Companies Need to get Prepared Agency (AGES), Austria Elena Bolanos, Director, European Clinical Operations, Eli Lilly, UK Challenges and Opportunities in the Implementation of the Falsified Medicine Discussion with all speakers Directive from Industry’s Perspective Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium Session 0105 | Thursday, 27 March, 09:00-10:30 | E1-OE
BIOSIMILARS - BUILDING ON EUROPEAN FOUNDATIONS TO ACHIEVE Session 0107 | Thursday, 27 March, 14:00-15:30| E1-OE GLOBAL HARMONISATION OPTIMISING REGULATORY OPERATIONS THROUGH USE OF INFORMATION Session Chair: TECHNOLOGY Judith MacDonald, Senior Director, Global Regulatory Lead, Pfizer Biosimilars, Session Chair: Pfizer, UK John Kiser, Senior Director, Regulatory Operations, AbbVie, USA
The session will review the fundamental tenets of the biosimilar concept This session will present information on how the regulatory environment can as pioneered by the European regulators and why upholding these is of evolve by embracing a new paradigm for worldwide regulatory submissions central importance in view of the fact that these concepts are sometimes enabled by information technology, what are the business drivers, what are the misunderstood by stakeholders. We will review the challenges faced by perceived cost and business benefits, what are the major barriers and enablers. companies in applying these concepts in a global setting and will conclude In the regulatory environment, balancing the need to be product focused while with a discussion on stakeholder education followed by a panel discussion. meeting the needs of all national regulators is key, the process for prioritising and producing and customising dossiers needs to be reconsidered, access to I. Keynote Address the company systems and the company knowledge base may change and maintaining validated business processes and technology systems can be seen European Regulation of Biosimilars - Past, present and future as a major challenge. Martina Weise, Head, Unit on Diabetes/Cardiology, Federal Institute for Drugs and Medical Devices (BfArM), Germany Globally Integrated Operations: How to develop a new regulatory model
that reduces cost of operations and enables regulatory strategists to focus II. Upholding the Biosimilar Concept as Pioneered in the EU: Challenges in on product strategy, compliance and regulators applying this globally Katy Page, Senior Director Submissions and Operations Support, Pfizer, UK
The Role of Analytics and Clinical Studies in the Development of Biosimilars Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in Joerg Windisch, Chief Science Officer, Sandoz Biopharmaceuticals, Austria the Global Regulatory Process Peter Lassoff, Vice President and Head of Global Regulatory Affairs, Quintiles, Overview of Regulatory Challenges in Applying the Biosimilar Concept UK Globally Judith MacDonald, Senior Director, Global Regulatory Lead, Pfizer Biosimilars, Regulator Evolution - Impact of technological change on the development Pfizer, UK and approval process, covering EU Telematics Roadmap, what this means for organisations, status with e-submissions around the globe and how this Education of Stakeholders on biosimilar concepts - Why does it matter enables regulator evolution Luc Verhelst, Head Information Technology Division, European Medicines globally? Virginia Acha, Director, Regulatory Affairs - R&D Policy, Amgen, UK Agency, EU
Session 0106 | Thursday, 27 March, 11:00-12:30 | E1-OE
CHALLENGES AND OPPORTUNITIES IN THE IMPLEMENTATION OF THE FALSIFIED MEDICINES DIRECTIVE DIA/EFPIA Information Day on ICH Session Chair: Maren von Fritschen, Managing Partner, Director Regulatory Affairs, PharmaLex, Germany
A falsified medicine is any medicinal product with a false/fake representation of its identity, source or history. The Falsified Medicines Directive, FMD (Dir 2011/62/EU) substantially changes the European framework for the supply of medicines.
The issues relating to the implementation of the FMD will be considered from the perspective of EU regulators, inspectorates and industry. This will include a review of the current status, practical aspects and options and effectiveness of required changes to further protecting patients from the scourge of fake medicines.
A panel discussion will give room for consideration of the perspectives of all involved parties. Event #14114 Challenges and Opportunities in the Implementation of the Falsified Medicine Directive from the Perspective of EU Regulators and Inspectorates 28 March 2014 Gerald W. Heddell, Director, Inspection Enforcement & Standards Division, Hotel NH Danube City, Vienna, Austria Medicines and Healthcare products Regulatory Agency (MHRA), UK
Optimising Labelling for a Digital Age Petra Wiesinger, Clinical Assessor and Qualified Person for Regulatory Affairs, Member of the QRD Working Group, Austrian Medicines and Medical Devices 24 theme 2
Theme 2 | HTA/Regulatory Interface assessments in reality and how are they used by payers when deciding Wills Hughes-Wilson, Vice President External Affairs, Chief Patient Access whether or not to reimburse a product? Payers will be asked what they do Officer, Sobi, Sweden with HTAs and how they include such assessments in their decision making. Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU G-BA’s Part in the Changing Situation of Payers in the HTA/Regulatory Environment The traditional regulatory pathway has changed considerably in recent years, Antje Behring, Department of Pharmaceuticals, Federal Joint Committee particularly in supporting the interface between HTA bodies and regulators. This (Gemeinsamer Bundesausschuss), Germany theme will look into the effect of these changes, whether they are delivering to those responsible for paying for drugs and services and ensuring that the EMA and NICE – How are their decisions viewed by a Clinical Commissioning right treatments reach patients in a timely manner. Participants will discuss Group? what still needs to change to smooth the pathway from drug development to Andrew Donald, Chief Officer, Stafford and Surrounds and Cannock Chase patient access, by providing the data required along that process. The theme Clinical Commissioning Groups, UK will explore whether it is possible to create a continuous dialogue and an integrated approach to a post-marketing evidence-generation plan. The Role of Payers in the HTA/Regulatory System - Does the economic environment make a difference? Session 0201 | Wednesday, 26 March, 09:00-10:30 | E2-OE Judit Bidló, Head of the Department of Medicines Reimbursement, National Health Insurance Fund, Hungary CREATING AN ADAPTIVE PATHWAY FOR MEDICINES TO PATIENTS - COULD THIS BE AN APPROACH THAT FULFILLS THE NEEDS OF ALL DECISION Session 0203 | Wednesday, 26 March, 14:00-15:30 | G-U2 MAKERS? A ROUNDTABLE DISCUSSION Session Chair: ESTABLISHED INTERACTIONS THROUGHOUT THE REGISTRATION Andrzej Rys, Director of Health Systems and Products, DG Sanco, European PATHWAY: WHAT EXISTS AND WHAT IS MISSING? Commission, EU Session Chair: Andrew Donald, Chief Officer, Stafford and Surrounds and Cannock Chase Would a move away from having the marketing authorisation as a “magic Clinical Commissioning Groups, UK moment” create an environment that meets the needs of all stakeholders in the drug development process? In other words, would “staggered”, “progressive”, There are multiple opportunities for interactions at different stages during or “adaptive” approaches, allowing authorisations for use in a defined patient the lifecycle of a drug. These are tending to start earlier and should continue population in certain situations, be one way to allow access to treatment early through post-marketing data generation. Are these interactions worthwhile on in the process, while still allowing regulators, treaters, HTAs and payers and for whom? How can these interactions be improved? Who should be the the data that they need on an ongoing basis. What would be the real-world players? What should be their role? benefits, barriers and enablers of such an approach? And what needs to change – if anything – to make this possible? Parallel scientific advice – A national perspective Wing Cheng, Coordinator Scientific Advice, the Dental and Pharmaceutical Regulator Perspective Benefits Agency (TLV), Sweden Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU HTA and EMA working Together: 20 parallel scientific advice procedures HTA Perspective later, what have we learnt? Jürgen Windeler, Director, IQWiG, Germany Jan Regnström, Senior Scientific Officer, Scientific Advice Office, European The Agency Perspective – European and national Medicines Agency, EU Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products Agency (MPA), Sweden Experience with HTA Authority Interactions throughout the Registration Pathway: An industry perspective HTA Perspective Jens Grueger, Head Global Pricing & Market Access, Pharma Division, Carole Longson, Executive Director, Centre for Health Technology Evaluation, F. Hoffmann-La Roche, Switzerland National Institute for Health & Care Excellence (NICE), UK Session 0204 | Wednesday, 26 March, 16:00-17:30 | G-U2 Patient Perspective Chris James, Director of External Affairs, Motor Neurone Disease Association, DATABASES, REGISTRIES AND OTHER DATA CAPTURE TOOLS: HOW CAN UK WE AVOID MULTIPLICITY AND CREATE AN INTEGRATED DATA-CAPTURE APPROACH ALONG THE PRODUCT DEVELOPMENT CYCLE? Industry / Company Perspective Session Chair Anton Hoos, Senior Vice President, Office of the Chief Medical Officer, Jens Grueger, Head Global Pricing & Market Access, Pharma Division, Roche GlaxoSmithKline, UK Pharmaceuticals, Switzerland
Session 0202 | Wednesday, 26 March, 11:00-12:30 | G-U2 Various data capture tools are being developed to address different needs at different stages of the product lifecycle. These include initiatives at HOW DO PAYERS VIEW CURRENT DEVELOPMENTS IN THE HTA AND national level – such as coverage with evidence development schemes – and REGULATORY ENVIRONMENT? at European level, for example the EUnetHTA EVIDENT database, the EMA’s Session Chair: data collection tools to support Post-Authorisation Efficacy Studies (PAES) Anna Bucsics, Former Department Head, Department of Pharmaceuticals and Post-Authorisation Safety Studies (PASS) and the European Network of Affairs, Main Association of Austrian Social Security Institutions, Austria Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). There is the possibility to create a wealth of data with these different tools, but how A variety of collaborative efforts have been undertaken in recent years to can these individual systems be integrated to create a data continuum that support the interface between HTA bodies and regulators. How are these supports informed decision-making by all actors and to avoid duplication? interfaces delivering to those that are responsible for paying for drugs and And are we missing opportunities provided by new technologies such as services? And, if Health Technology Assessments (HTAs) are carried out eHealth? to support the decision-making process for payers, how useful are these THEME 2 25
Integrating our Data Capture Tools – The regulatory perspective Session 0208 | Thursday, 27 March, 16:00-17:30 | G-U2 Peter Arlett, Pharmacovigilance Department, European Medicines Agency, EU ARE OUR HEALTHCARE SYSTEMS READY TO SUPPORT THESE AP- PROACHES? WHAT – IF ANYTHING – NEEDS TO CHANGE? A ROUNDTABLE Integrating our Data Capture Tools – The HTA perspective DISCUSSION Finn Børlum Kristensen, Director, EUnetHTA, Danish Health and Medicines Session Chair: Authority, Denmark Wills Hughes-Wilson, Vice President External Affairs, Chief Patient Access Officer, Sobi, Sweden Integrating Data Capture Tools to Make the Most of Data – The patient perspective If the systems are being developed to ensure that a dialogue is possible Yann Le Cam, CEO, EURORDIS, France to create target populations that are agreed by all stakeholders in the development lifecycle, what impact will that have on the practice of medicine? Session 0205 | Thursday, 27 March, 09:00-10:30 | G-U2 Are we ready to work in an integrated way and, if not, what needs to change? MARKETING AUTHORISATION AND BEYOND: MOVING FROM EARLY DIALOGUE TO CONTINUOUS DIALOGUE – CREATING AN INTEGRATED Patient Perspective RESEARCH AND DEVELOPMENT PATHWAY: PROVIDING A ‘ONE-STOP Christoph Thalheim, Vice CEO & Director External Affairs, European Multiple SHOP’ FOR INDUSTRY? Sclerosis Platform (EMSP), Belgium Session Chair: Jérôme Boehm, Team Leader, e-Health and Health Technology Assessment, Industry Perspective DG Sanco, European Commission, EU Richard Bergström, Director General, European Federation of Pharmaceutical, Industries and Associations (EFPIA), Belgium Is it possible to develop a system of integrated, comprehensive scientific advice that brings together early and late dialogue, to inform the lifecycle of drug Authority / Ministry Perspective development, not just what is required to secure a marketing authorisation, Hugo Hurts, Director Pharmaceutical Affairs & Medical Technology, Ministry of but also to address the evidence required in support of value proposition Health, Welfare & Sports, the Netherlands and access? This could include scientific advice at phase 2, at the point of marketing authorisation and during post-marketing authorisation evidence The Future Policy Perspective generation. Would this, in fact, enable sponsors to have just one integrated Thomas Heynisch, Deputy Head of Unit, Food and Healthcare Industries, research pathway, rather than generating different data for regulators, HTA Biotechnology, DG Enterprise, European Commission, EU bodies and payers throughout the product life-cycle? And could this be provided by an EU-wide “one-stop shop”? A Payer's Perspective Klaus Klaushofer, Medical Director of Hanusch Hospital, Head of 1st Medical How will Industry Contribute to Making Increased Collaboration Deliver Department in Hanusch Hospital, Consultant Physician of the Main Association Value to Society and Patients? of Austrian Social Insurance Institutions, Austria Birgitte Volck, Chief Medical Officer, Sobi, Sweden
An Integrated Pathway in Practice – A national perspective th Paolo Siviero, Head of Office, Italian Medicines Agency (AIFA), Italy 8 European Forum for Qualified Person for Pharmacovigilance How Can the EMA Contribute to a One-Stop Shop? Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU (QPPV)
Session 0207 | Thursday, 27 March, 14:00-15:30 | G-U2 Event #14104 HOW DO WE BRING THE PATIENT’S VOICE INTO THE DISCUSSION? HOW 14-15 May 2014 DO WE ENSURE THAT ALL THE RIGHT VOICES ARE HEARD? Millennium Gloucester Hotel London Kensington, UK Session Chair: 13 May 2014 | Pre-Conference Workshop Josie Godfrey, Associate Director – Highly Specialised Technologies, National Institute for Health and Care Excellence (NICE), UK
What is the reaction of stakeholders to the idea of an integrated research pathway? Will this simplify the drug development and post-marketing authorisation process, rather than continuing with the “silo’ed” approach? How will such a process work in practice and how do we ensure that the right people are involved at the right time, including the patients? What is the potential future role of patients in the drug review process?
Societal Decisions and the Patient’s Voice Mary Baker, President, European Brain Council, UK
Measuring the Burden of Not Being Treated – the BUR-QOL study Panos Kanavos, Deputy Director, LSE Health, London School of Economics (LSE), UK
Conjoint Analysis Research – A scientific methodology to bring patient values into the process Maarten J. Ijzerman, Chair Dept. Health Technology & Services Research, University of Twente, the Netherlands 26 theme 3 | theme 4
Theme 3 | Benefit/Risk Management and Lifecycle A Framework and Minimum Dataset for Patient-Reported Outcomes in Approach Adverse Event Reporting (PRO-AEs) Swapu Banerjee, Deputy Managing Director, Pope Woodhead & Associates Valerie Simmons, EU QPPV, Global Patient Safety, Eli Lilly & Company, UK Ltd, UK Tomas Salmonson, Chair Committee for Medicinal Products for Human Use (CHMP), Senior Scientific Advisor, Medical Products Agency (MPA) Sweden Implementation of a Structured B/R Profile Approach into Drug Development European Pharmacovigilance Legislation is one of many stimuli shaping a Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer new paradigm in benefit/risk management throughout the lifecycle of a Pharmaceuticals, Germany medicine. There is more emphasis on the key drivers of a product's benefits and risks, how to study these parameters in a real world setting, how to Linking Critical Quality Attributes (CQAs) to the Benefit/Risk Calculus evaluate and re-evaluate changes throughout development and how to John Ayres, Senior Director, Product Safety Assessment, Eli Lilly & Co., USA effectively communicate what can be complex concepts to all stakeholders in an increasingly transparent global environment. This approach has prompted Session 0304 | Wednesday, 26 March, 16:00-17:30 | E2-OE fundamentally new ways of working, the need for new skill sets and closer interactions across functional boundaries not usual in traditional organisational CURRENT INDUSTRY PRACTICE FOR BENEFIT/RISK GOVERNANCE models. This theme will explore various aspects of this "Brave New World", Session Chair: and examine the extent to which it has met its objectives in promoting patient Anne Bouvier, Director and Head of Benefit Risk Management and Process safety. Innovation, UCB Pharma, Belgium
A case study will be used to illustrate changes made to a company’s existing Session 0101/0301 | Wednesday, 26 March, 09:00-10:30 | B-O2 safety risk governance model to include expanded functional stakeholders PANEL DISCUSSION: MAKING THE PHARMACOVIGILANCE LEGISLATION necessary to align on a comprehensive benefit/risk characterisation. The WORK – A TEMPERATURE CHECK session will also review the ongoing debate regarding the qualitative vs. Session Chair: quantitative methods used for benefit/risk evaluations and the importance Vicki Edwards, QPPV and Head of Affiliate Vigilance Excellence, Global of standardised process. Finally, an approach for achieving an integrated Pharmacovigilance, AbbVie Ltd., UK lifecycle approach to benefit/risk evaluation and the current industry practices in operationally addressing new requirements will be explored. Industry This session will explore experiences and impact to date of the implementation benchmarking data will be referenced to characterise current practices in of the new pharmacovigilance legislation from the point of view of multiple organisation & governance, benefit/risk assessment processes, benefit/risk stakeholders. The new legislation has had impact across a broad range of source data and the challenging areas for development. safety related activities however this session will focus on areas where we have seen fundamental changes. The session will be conducted as a panel A Case Study to Illustrate the Benefit/Risk Evaluation Process and Governance discussion where views from a PRAC member, a Member State Competent Anne Bouvier, Director and Head of Benefit Risk Management and Process Authority, the industry and a patient perspective will be heard. The panel Innovation, UCB Pharma, Belgium will consider if the objectives of the new legislation are yet being met in particular with respect to the need to consider risks in the context of benefit, Evaluation of Qualitative Benefit/Risk Assessment Methods the increased focus on management of risk in the post-marketing environment Lesley Wise, Vice President, Global PV Risk Management and and the role of the Pharmacovigilance Risk Assessment Committee (PRAC). Pharmacoepidemiology, Takeda, UK The panel will also discuss their views on the impact of the transparency measures on communication and decision making. Current Industry Best Practices and Achieving Lifecycle Integration Sharmila Sabaratnam, Senior Consultant, WCI Consulting, Ltd., UK Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), the Netherlands Session 0305 | Thursday, 27 March, 09:00-10:30 | E2-OE
Theo Raynor, Professor of Pharmacy Practice, School of Healthcare, University PANEL DISCUSSION: TRANSPARENCY IN THE PHARMACEUTICAL SECTOR – of Leeds, UK WHAT HAVE WE LEARNED? Session Chair: June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, Ragnar Lofstedt, Professor of Risk Management, Kings College, UK MHRA, UK Following the complaint of the Nordic Cochrane Centre to the European Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer Ombudsman regarding EMA’s refusal to release clinical trial data because Pharmaceuticals, Germany of commercial interests, transparency has become a hot policy topic in Europe. In this panel discussion we discuss some of the recent developments Maria-Grazia Zurlo, QPPV, Pfizer, UK in the transparency domain s uch as the increased visibility of the “All trials campaign”, the release of Periodic Safety Upgrade Reports (PSURs) and Session 0302 | Wednesday, 26 March, 11:00-12:30 | E2-OE what may happen next in this important policy domain. Also of interest for the panel is what have we learned from past experiences? Has increased THINKING BEYOND OLD PHARMACOVIGILANCE BOUNDARIES transparency led to greater levels of public trust in the pharma regulators and Session Chair: or help patients/the public make informed choices regarding taking specific John Ayres, Senior Director, Product Safety Assessment, Eli Lilly & Co., USA medicines?
The session will explore opportunities where pharmacovigilance scientists Carmen R. Bozic, Senior Vice President, Global Head, Safety and Benefit/Risk might bring their expertise into the drug development design space. Management, Biogen Idec, USA Incorporating the voice of the patient into safety study design and identifying benefit/risk attributes early in development will be discussed. Faraz Kermani, Senior Editor Europe, The Pink Sheet, Informa Business Intelligence, UK
Martin Harvey Allchurch, Head of Communication, European Medicines theme 3 27
Agency, EU Session 0308 | Thursday, 27 March 16:00-17:30 | E2-OE Session 0306 | Thursday, 27 March, 11:00-12:30 | E2-OE RISK MINIMISATION AND ITS EFFECTIVENESS – WHAT IS STATE OF THE MOVING FROM RISK MANAGEMENT TO BENEFIT/RISK MANAGEMENT ART AND WHAT IS REALISTIC? PLANNING Session Chair: Session Chair: Stephen Heaton, Head of Risk Management Planning and Coordination, Susana Perez-Gutthann, Vice President, Global Head Epidemiology, Global Pharmacovigilance, Bayer Healthcare, Germany RTI Health Solutions, Spain This session will provide an overview of different perspectives regarding European pharmacovigilance legislation has driven the integration of benefit advances in pharmaceutical risk minimisation – regulatory, academia, and and risk evaluations in the approval and post approval lifecycle. This has a CIOMS IX profound impact on the planning of risk management activities and safety Regulatory Perspective on Risk Minimisation and Effectiveness research in a real world setting. The session will provide a regulatory guidance Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), and recommendations and how this changes planning of the risk management the Netherlands strategy and the study portfolio from an industry and research centre perspective. Practical Experience with Risk Minimisation Tools and Measurement of Effectiveness From Risk Management to Benefit/Risk Management Planning: A regulatory Saad Shakir, Director, Drug Safety Research Unit, UK perspective Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products CIOMS IX: Perspectives on Risk Minimisation and Effectiveness Agency (MPA), Sweden Stephen Heaton, Head of Risk Management Planning and Coordination, Global Pharmacovigilance, Bayer Healthcare, Germany From Risk Management to Benefit/Risk Management Planning: An industry perspective N. Jamie Robinson, Global Head, Epidemiology, Patient Reported Outcomes and Healthcare Data Strategy, F. Hoffmann-La Roche, Switzerland
Incorporating Benefits in Assessments and Epidemiology Studies: A research center perspective Susana Perez-Gutthann, Vice President, Global Head Epidemiology, RTI Health Solutions, Spain
Session 0307 | Thursday, 27 March, 14:00-15:30 | E2-OE
PERIODIC BENEFIT RISK EVALUATION REPORTING – HAS IT ACHIEVED WHAT IT SET OUT TO DO? Session Chair: Craig Hartford, Vice President, Safety Surveillance and Risk Management, Worldwide Safety Strategy, Pfizer Medical, UK
The Periodic Benefit Risk Evaluation Report ICH E2C (R2) Guidance reached Step 4 of the ICH process in November 2012. In this session we evaluate, based 8–10 May 2014 on experience to date, whether the main objective of the PBRER is being met viz. to present a comprehensive, concise, and critical analysis of new or Andel’s Hotel, Berlin, Germany emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit- th risk profile. 7 European Conference on
A Regulatory Perspective on the Achievement of PBRER Objectives Rare Diseases & Orphan Products Almath Spooner, Vice-Chair, PRAC, Pharmacovigilance and Risk Management Lead, Irish Medicines Board (IMB), Ireland (ECRD 2014 Berlin) The Rare Disease Puzzle: A Pharmaceutical Industry Perspective on the Achievement of PBRER Objectives Bringing the Picture to Life Barbara de Bernardi, Deputy QP, Pfizer, UK www.rare-diseases.eu Panel Discussion- Periodic Benefit/Risk Evaluation - Has it achieved what it set out to do? This panel will include industry and regulator subject matter experts including Organised by Co-organised by With the support of session speakers and
Valerie Simmons, EU QPPV, Global Patient Safety, Eli Lilly & Company, UK
June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, MHRA, UK
Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), the Netherlands 2014Brussels 23-25 Berlin May 2012 28 theme 4
Theme 4 | Special Populations Session 0403 | Wednesday, 26 March, 14:00-15:30 | H-U2 Judith Creba, Head EU Liaison & Policy, Novartis Pharma, Switzerland DEVELOPING MEDICINAL PRODUCTS FOR OLDER PEOPLE - GETTING ON TRACK Special populations such as children and the elderly require particular attention Session Chair: during drug development. The Paediatric Regulation has slowly started to Markku Toivonen, NDA Advisory Board - Scientific Director, NDA Group, UK deliver better and more data for medicines used in children, and the European Commission’s conclusions after 5 years of experience has been published. The Rational pharmacotherapy in the older population requires fit-for-purpose latest developments in paediatrics from the perspective of all stakeholders will data for benefit risk assessment at the time of marketing application. Specific, be covered. early attention is required in designing clinical programs and in providing regulatory input. The changing demographics and aging of populations are increasing the need to provide safe and effective medicines for the older population. This theme EMA Geriatric Strategy – What is it and how is it delivering? will explore the various initiatives and strategies to address specific issues in Jordi Llinares, Head of Product Development Scientific Support, European developing medicinal products for use in older people. Medicines Agency, EU
Optimising Clinical Trial Design and Conduct to Support Benefit/Risk Session 0401 | Wednesday, 26 March, 09:00-10:30 | H-U2 Assessment in Older Patients PAEDIATRIC REWARDS - WHERE DO WE STAND? WHAT ARE THE Florian von Raison, Senior Global Program Head and Chairman Geriatric OBSTACLES, AND HOW COULD THE SYSTEM BE IMPROVED? Medicine Working Party/ EFGCP, Novartis, Switzerland Session Chair: Geneviève Michaux, of Counsel, Hunton & Williams, Belgium Benefit/Risk Assessment in Older Patients in the Pre- and Post- Authorisation The session discusses the difficulties faced by the industry for being rewarded Andrea Laslop, Head of Scientific Office, Austrian Medicines and Medical for their paediatric development and examines the possible solutions. Devices Agency (AGES), Austria
SPC Extensions – What are national patent offices demanding? Lawrence Cullen, Deputy Director (Biotechnology, Pharmaceuticals & Organic Chemistry), Intellectual Property Office, UK 8th European Medical Information Orphans – Where are the rewards? Antonella Cominetti, Associate Regulatory Affairs Director, Europe, Shire, and Communication Conference Switzerland & Exhibition
PUMA – Could it be worthwhile? John Watson, Senior Director Regulatory Affairs Europe, ViroPharma, UK Event #14103 Session 0402 | Wednesday, 26 March, 11:00-12:30 | H-U2 23-24 September 2014 Millennium Gloucester Hotel London Kensington, UK LATEST DEVELOPMENTS IN PAEDIATRICS Session Chair: Christina Bucci-Rechtweg, Head, Pediatric & Maternal Health Policy, Global Drug Regulatory Affairs, Novartis Pharmaceuticals, USA
The Paediatric Regulation has set the stage to advance the development of better medicines for children within the broader global regulatory environment. A PDCO representative will provide his vision for the future of pediatric drug development in the EU. A representative from the EMA and an industry representative will provide their perspectives on new developments related to paediatrics, and provide an outlook on opportunities and challenges that lie ahead.
The PDCO’s Perspective: 2014 and Beyond Koen Norga, Vice-Chair PDCO, Head of Clinic, Paediatric Oncology, Antwerp University Hospital, Belgium
Opportunities and Challenges: An EMA perspective Jordi Llinares, Head of Product Development Scientific Support, European Medicines Agency, EU
Opportunities and Challenges: An industry perspective Kate Beaujeux, Senior Regional Regulatory Affairs Director, AstraZeneca, UK theme 5 29
Theme 5 | Personalised Medicine: Drug-companion Developments in Companion Diagnostics/PHC diagnostics combinations Rainer Metzger, Vice President Global Business Development Pharma, Qiagen, Germany Tim Kievits, Director Healthcare Innovation, Vitromics Healthcare, the Netherlands Introduction of Therapy/Test Combination in Clinical Practice Anna Bucsics, Former Department Head, Department of Pharmaceuticals Robert Mader, Director of Translational Research, Medical University Clinics – Affairs, Main Association of Austrian Social Security Institutions, Austria Vienna General Hospital, Austria Personalised medicine refers to the strategy of trying to identify responders Session 0503 | Wednesday, 26 March, 14:00-15:30 | I-U2 to a specific treatment before initiating therapy. The FDA and EMA already encourage the inclusion of companion diagnostics during development of HEALTH ECONOMIC ASPECTS OF PERSONALISED MEDICINES medicines and in the market. However, co-development and assessment of Session Chair: therapies and associated diagnostics, also called companion diagnostics, Sabine Vogler, Head of Pharma Team, PPRI Project Manager, Austrian Health is challenging. The pharmaceutical industry and payers, such as national Institute (Gesundheit Österreich Gmbh), Austria healthcare services or health insurers, for different reasons, worry about the business and economic consequences of developing therapies for small Personalised medicine approaches aim at assuring optimal use of healthcare groups of patients. Furthermore personalised medicine currently seems to be budgets by only providing a therapy to those patients that benefit from the a mostly technology driven topic while other equally important aspects such treatment. However this approach drives towards many different and often as socio-ethical, organisational and educational/training challenges are not yet more expensive treatments. This session will address the question: How to adequately addressed. make personalised medicine affordable?
This complex and unresolved situation will be discussed in the Personalised Pre-empting Problems for Personalised Medicine Adoption in the Market Medicine theme covering: Brian Godman, Senior Researcher, Karolinska Institute, Division of Clinical • A description of the current status and latest developments Pharmacology, Karolinska University Hospital, Sweden • Discussion of bottlenecks and visions on how to implement personalised medicine European Payers Overview on Reimbursement • Next steps on a practical basis for healthcare professional Claudia Habl, Head of Austrian Pharmaceutical Price Information (PPI-Service), Austrian Health Institute (Gesundheit Österreich Gmbh), Austria
Session 0501 | Wednesday, 26 March, 09:00-10:30 | I-U2 The Importance to Value Diagnostics TRANSLATION OF PERSONALISED MEDICINE CONCEPTS Yullie Matsouka, Vice President Medical Shared Services, Roche Diagnostics, Session Chair: Switzerland Michael Zühlsdorf, Senior Director Oncology, Global Head Translational and Biomarker Research, Merck Serono Global Research and Early Development, Balancing Public and Private Interests in the Insured Package Merck KGaA, Germany Martin van der Graaff, Secretary of the Scientific Evaluation Committee, Health Care Insurance Board, (CVZ), the Netherlands This session addresses the latest scientific developments driving personalised medicine, adaptive trial concepts supportive of personalised medicine and Session 0504 | Wednesday, 26 March, 16:00-17:30 | I-U2 early scientific advice for the development of personalised medicine from regulators, HTA bodies and payers. THE SOCIETAL PERSPECTIVE ON PERSONALISED MEDICINE - MANAGING THE PARADIGM SHIFT Latest Scientific Developments/New Biomarker Technologies Session Chair: Giulio Superti-Furga, Scientific Director, Research Center for Molecular Brian Godman, Senior Researcher, Karolinska Institute, Division of Clinical Medicine of the Austrian Academy of Sciences, Austria Pharmacology, Karolinska University Hospital, Sweden
Scientific Advice from Regulators The introduction of personalised medicine asks for adoptions of many Jan Regnström, Senior Scientific Officer, Scientific Advice Office, European stakeholders. How are we going to manage the paradigm shift in the healthcare Medicines Agency, EU sector to assure fast adoption of personalised medicine?
Adaptive Enrichment Files Can Society Afford Personalised Medicine? Zoran Antonijevic, Senior Director, Strategic Consulting and Adaptive Claudia Wild, Director, Ludwig Boltzmann Institute for Health Technology Implementation, Cytel, USA Assessment, Austria
Session 0502 | Wednesday, 26 March, 11:00-12:30 | I-U2 Patient Representative’s View on Personalised Medicine Durhane Wong-Rieger, Chair of the Bard, International alliance of Patient FROM BIOMARKERS TO COMPANION DIAGNOSTICS Organisations (IAPO), Co-Vice-Chair, Steering Committee of HTA International Session Chair: Interest Group on Patient/Citizen Involvement, Canada Jens Grueger, Head Global Pricing & Market Access, Pharma Division, F. Hoffmann-La Roche, Switzerland Industry-Society Interactions are Essential to Make Promises of Personalised Medicine Come True This session will cover validation and regulation of drug-diagnostics Alexander Roediger, Director European Union Affairs, MSD Europe, Inc., combinations, introduction of personalised medicine innovations in clinical Belgium practice, corporate and governmental pharmaceutical and diagnostic coordination, and introduction of personalised medicine in to clinical practice. Introduction of Personalised Medicine in East European Economies Maria Judit Molnar, Vice Rector, Semmelweiss University, Professor of Genomic Current Regulation and Challenges for Biomarker and Companion IVD Medicine and Rare Diseases, Hungary Development – Focus on biotech products Jörg Engelbergs, Scientific Expert Antibody Therapeutics, Paul-Ehrlich- Institut, Germany 30 theme 6
Theme 6 | Innovation in Clinical Research Session 0604 | Wednesday, 26 March, 16:00-17:30 | F1-OE Clara Heering, Vice President Clinical Risk Management, ICON Clinical OPTIMISING CLINICAL RESEARCH: WHICH INFRACTURIAL AND BUSINESS Research, Belgium RELATIONSHIP CHANGES DO WE NEED TO CONSIDER? , Director, Explicator, Ltd., UK Carl Naraynassamy Session Chair: Beat Widler, Managing Partner, Widler & Schiemann, Switzerland Risk-Based Monitoring (RBM) regulations, new technologies organising aggregated sources of digital data, as well as advances in behavioural sciences The presenters will consider changes required to the established infrastructure provide new responses to the industry’s search for optimised clinical research for providing clinical research services in order to accommodate risk based paradigms. We need to ascertain that the paradigm shifts are founded on monitoring. The evolution in the business relationships over outsourcing will robust assessments of risk and evidence of qualitative and effective processes, be specially considered. verify that investigators, monitors and project managers are empowered in their decision making and satisfy ourselves that the greater reliance on digital New Landscape: CRO and Biopharma partnerships in RBM data enhances patient safety and ethical conduct of clinical research. What Regina Freunscht, Vice President, Global Research & Development Quality are the lessons learned and benchmarks to date in this new era of clinical Assurance, Merck Serono, Germany research? Infrastructure Changes Required for RBM and their Change Management Session 0601 | Wednesday, 26 March, 09:00-10:30 | F1-OE Implications Beat Widler, Managing Partner, Widler & Schiemann, Switzerland THE IMPORTANCE FOR ALL TO ADOPT THE NEW PARADIGM IN CLINICAL RESEARCH: INTRODUCTORY SESSION Performance and Quality Monitoring Systems Session Chair: Andreas Grund, CEO, GCP-Service International, Germany Clara Heering, Vice President Clinical Risk Management, ICON Clinical Research, Belgium Debate: Old versus New: Opportunities and challenges of both systems Attendees will be brought to speed on the various pan-industry initiatives over RBM. The speakers will situate RBM in the context of optimising drug Session 0605 | Thursday, 27 March, 09:00-10:30 | F1-OE development, the regulatory framework for conducting research and its INNOVATIVE METHODOLOGIES USED IN ENHANCING QUALITY impact on study participants. Session Chair: Sherri A. Hubby, Director, US Quality Assurance, Premier Research Group, USA Industry Perspective Jessica Holthuizen, Clinical Operations Head CVM, Janssen Pharmaceuticals, In this session, the speakers focus on specific novel methodologies which Belgium (representing TransCelerate BioPharma Inc.) improve quality to improve three aspects of drug development which always prove to be challenging. EMA Perspective Ana Rodriguez, Head of Clinical and Non-clinical Compliance, European Use of Virtual Population Simulation to Improve Protocol Design and Medicines Agency, EU Amendment Management Badri Rengarajan, VP, Medical Affairs and Strategic Consulting, Evidera, USA Patient Perspective Patient to be confirmed at session time Incorporating Risk-Based Monitoring Strategies: Challenges and implementation from industry and regulators Session 0603 | Wednesday, 26 March, 14:00-15:30 | F1-OE Sherri A. Hubby, Director, US Quality Assurance, Premier Research Group, USA
THE NEW PARADIGM IN CLINICAL RESEARCH: THE CASE FOR DEVELOP- Identifying Patients at Risk in Clinical Trials Using Data Mining and Data ING NEW ROLES, SKILLS AND COMPETENCIES Visualisation Technologies Session Chair: Robbert van Manen, Master Principal Solutions Consultant, Oracle Health Carl Naraynassamy, Director, Explicator, Ltd., UK Sciences, the Netherlands
The presenters will discuss how the changes in monitoring practices call for Session 0606 | Thursday, 27 March, 11:00-12:30 | F1-OE adapted competencies in those who work closely on the collection of study data. The debate will focus on ways and means to maximise the acquisition of WORKSHOP: THE NEW PARADIGM IN CLINICAL RESEARCH: STAKEHOLDER these adapted competencies. PERSPECTIVES FOR A RATIONAL PROCESS Session Co-Chairs: Evolution of Risk Management Processes Peter Stokman, Head Global Data Management & Standards Oss, Merck Brendon Binneman, Senior Director, Pfizer, USA Sharpe and Dohme, the Netherlands Clara Heering, Vice President Clinical Risk Management, ICON Clinical Evolution of the Monitor Role Research, Belgium Yvonne Barnes, Senior Director Global Clinical Site Monitoring, Quintiles, UK In the first part, the speakers focus on the rationale and applicability of Evolution of Study Sites and Investigator Interface prioritising limited resources to crucial sectors. Key regulatory documents Karolien De Roeck, Associate Clinical Operations Director, Site Management are analysed and drivers such as ‘proportionality’ are reviewed. In the and Monitoring, AbbVie, Belgium second part, ‘complicating factors’ are discussed in small groups. This is a challenge to the audience to think freely on how to break away from company Debate: How to diminish resistance to change and engage the full clinical culture and thinking, and to provide and justify ideas for reconfiguring the research team current process. The complicated factors covered are: the fragmentation of responsibilities linked to the specialisation of service providers; risk aversion and the reluctance to change current practices; business practices which stifle innovation; misconstrued and over-interpreted regulatory requirements which lead to perverse results. theme 6 | Theme 7 31
Current Pharma Solutions to Address Protocol Data Relevance Theme 7 | eClinical: Reaching Out Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Peter Stokman, Head Global Data Management & Standards Oss, Merck Development, USA Sharpe and Dohme, the Netherlands
Data-Driven Clinical Development: A means by which the pharmaceutical Over the last decade, ‘Clinical’ took a giant leap to become ‘eClinical’. This industry can improve its productivity and efficiency greatly increased the possibilities for speeding up, increasing quality, Sarah Athey, Director, European Consulting, Quintiles, UK performing new types of studies and analyses, streamlining the data flow, and in general taking clinical development to the next level. During this session Ana Rodriguez, Head of Clinical and Non-clinical Compliance, European the added value, implications and future perspectives of eClinical will be Medicines Agency, EU presented in an understandable way to the various (non-technical) disciplines involved in pharmaceutical development. Gabriele Schwarz, Head GCP Inspectorate, Federal Institute for Drugs and Medical Devices (BfArM), Germany Session 0701 | Wednesday, 26 March, 09:00-10:30 | K-U2 Session 0607 | Thursday, 27 March, 14:00-15:30 | F1-OE eTRIAL MASTER FILE: CLINICAL IN THE CLOUD(S)? SYSTEMATIC APPROACHES TO DELIVER QUALITY: LEARN FROM THE Session Chair: EXPERTS! Peter Stokman, Head Global Data Management & Standards Oss, Merck Session Chair: Sharpe and Dohme, the Netherlands Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science, UK Over the last couple of years, the greatest advances in eClinical have been made in the data collection arena. The ‘next big thing’ for many companies In this session, three experts reflect on practical ways to achieve quality. is the leap to full electronic storage of the clinical documentation required to ensure regulatory compliance. During this session, the need, the issues and Applying Risk Assessment in Risk-Based Monitoring the benefits will be addressed, including how ‘The Cloud’ can be leveraged as Niall Barron, Clinical Data Strategy, RD Projects Clinical Platforms & Sciences, adata repository. GlaxoSmithKline, UK Cloud Computing Solutions for the Clinical Environment Rob Nichols, General Manager Europe, DATATRAK, UK Realising Time and Cost Savings through Protocol Design Planning Improvements Horses for Courses - is the eTMF really a document management problem? Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Jonathan Burd, Solution Director, GxPi, UK Development, USA eTMF in Clinical Trial Management - improve your clinical operations What Can Safety Engineering Teach Us about Better Controlling Clinical efficiency Safety and Managing Risk? Rik Van Mol, Vice President R&D, Veeva Vault Europe, Belgium Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science, UK Session 0702 | Wednesday, 26 March, 11:00-12:30 | K-U2
eCLINICAL: FASTER, BETTER, HIGH-QUALITY TRIAL SET-UP AND CONDUCT Session 0608 | Thursday, 27 March, 16:00-17:30 | F1-OE Session Chair: THE BRAVE NEW WORLD OF DIGITAL DATA: WHAT ARE THE NEW LEGAL Isabelle de Zegher, Worldwide Senior Director, Clinical Data Standards, AND ETHICAL QUESTIONS? Perceptive Informatics, Belgium Session Chair: Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Increased efficiency in clinical trial execution remains a key target. This session will explore more particularly three aspects: faster system set-up, increased The session addresses some ethical and legal repercussions of collecting compliance of investigators and opportunities for improved monitoring by patients’ data digitally. The potential impact on data privacy is covered as CRA. well as the likely education that subjects will need to enable them to make informed decisions on the release of their personal data. Implementation of eProtocol BRIDG Structure toward Increased Efficiency in Data Collection, Submission and Data Integration Lack of Reproducibility or Why Most Published Research Findings Are False Isabelle de Zegher, Worldwide Senior Director, Clinical Data Standards, Joachim Vollmar, Executive Consultant, International Clinical Development Perceptive Informatics, Belgium Consultants LLC, USA Using Gamification to Incentivise Sites Niki Kutac, Product Manager, DATATRAK International, USA Ethical and Privacy Considerations for the Brave New World of Risk-Based Approaches Trends in Global Clinical Research Monitoring: A Perspective from the field, Nicholas Alp, Vice President Science Council Global Therapeutics, ICON, UK Annual Survey on the State of the Industry Scott Freedman, President, MonitorForHire.com, USA Debate: What will digital data mean for patient education? Panel with all speakers Session 0703 | Wednesday, 26 March, 14:00-15:30 | K-U2
eCLINICAL: FROM CASE DECISIONS TO STRATEGIC ALIGNMENT Session Chair: Detlef Nehrdich, Senior Associate, Waife and Associates Inc., Germany
This session will focus on the strategic of aspects eClinical solutions. Examples of ePRO, EDC and a clinical portal will be used to describe how to prepare organisations strategically for the implementation of different eClinical solutions. 32 theme 7 | theme 8
How to Implement an ePRO Strategy: A best practices guide at global level. The action plan emphasises activities at the EU level, but it Frans Wald, Global Head Clinical Trials Support, Boehringer-Ingelheim, encourages all stakeholders such as national and regional authorities, health Germany and social care providers, professional organisations, researchers and patients to be active in this area and working closely together. Successful Usage of Cloud-Based Clinical Portals both with CROs, Investiga- tors and Internally Introduction to the eHealth Action Plan John Aggerholm, Project Director, HERAX, Denmark Paul Timmers, Director ICT addressing Societal Challenges, Directorate General EDC for Small to Mid-Size Companies Information Society and Media, European Commission, EU Steffen Koenig, General Manager and Head of Quality Assurance, IST GmbH, eHealth, mHealth and Apps Germany Erik Vollebregt, Partner, AXON Lawyers, the Netherlands Bernard Brandewiede, Managing Director, Amedon, Germany Innovation Partnership on Active and Healthy Ageing Session 0704 | Wednesday, 26 March, 16:00-17:30 | K-U2 Elena Mancini, Product Manager, Daiichi Sankyo Italia, Italy
DATA INTEGRATION: REACHING THE NEXT LEVEL OF EFFICIENCY Session 0806 | Thursday, 27 March, 11:00-12:30 | H-U2 Session Chair: Philippe Verplancke, Managing Director, XClinical, Germany INTEROPERABILITY FOR HEALTHCARE PROVIDERS ACROSS THE EU Session Chair: During the last decade, EDC systems and other eClinical technical components Terje Peetso, Policy Officer, Directorate General Communications Networks, have been widely adopted. But industry still struggles and many are sceptical Content and Technology, European Commission, EU whether technology really brings more efficiency compared to the old way of doing clinical trials. This session will show approaches to take the next Interoperability of ICT-enabled solutions and of data exchange is the technological steps and how this can completely change the way we do precondition for better coordination and integration across the entire chain clinical research today. of healthcare delivery and health data exchange. Equally important are the The Future of Clinical Trials following four aspects of the interoperability: legal, organisational, semantic Serge Van der Geyten, Associate Director Global Regulatory Affairs – and technical. Neuroscience, Janssen Research and Development, Belgium Interoperability Making it Work: Bringing technology together to produce useful data Scott Adams, Practice Lead- Interoperability, Global Health Portfolio & Carmen Weese, Associate Director, Data Management, INC Research, USA Practices, BT Global Services, UK
Advantages of a Real End-to-End Approach with CDISC Standards epSOS: Interoperability in respect to the eHR and ePrescription Philippe Verplancke, Managing Director, XClinical, Germany Marcello Melgara, LIspa c/o Health Information System and International Health Projects, Lombardy Region, Regional Government, Health Ministry, Italy
Theme 8 | Innovation in Healthcare and its Impact Translational & Interoperable Health Infostructure - The servant of three on Industry masters Amnon Shabo, Head, Healthcare and Life Sciences Standards Hans van Bruggen, Director, eCTDConsultancy, the Netherlands Program, IBM, Israel Terje Peetso, Policy Officer, Unit H1 - Health and wellbeing, Directorate General Communications Networks, Content and Technology (DG CONNECT), Session 0807 | Thursday, 27 March, 14:00-15:30 | H-U2 European Commission, EU BIG DATA, eHEALTH RECORDS AND TAXONOMY Session Chair: Efficient and sustainable healthcare systems, such as eHealth, are needed to Hans van Bruggen, Director, eCTDConsultancy, the Netherlands maintain and improve overall public health. eHealth includes efficient exchange of clinical trial data, eHealth Records and ePrescriptions across the IT systems. The goal of the European Network of Centres for Pharmacoepidemiology and This requires interoperable systems for healthcare professionals, patients/ Pharmacovigilance (ENCePP) is to further strengthen the post-authorisation citizens, epidemiologists and pharmaceutical industry. Remote access and monitoring of medicinal products in Europe by facilitating the conduct of interoperability allows for mobile health, including smart phones/tablets and multi-centre, independent, post-authorisation studies focusing on safety social media apps. The use of smart mobile devices will increase the amount and on benefit/risk, using available expertise and research experience across of electronically available information and improve therapy compliance. The Europe. Gathering this kind of data in ONE taxonomy database leads to greater use of social media augments the power of the public on how therapies are interoperability between pharmaceutical industry, healthcare professionals perceived. All these support patient empowerment. and patients. However, until now there has been a shortage of fully integrated informatics solutions that can handle data from multiple sources. Integration of these multiple platforms might achieve personalised medicine in the future. Session 0805 | Thursday, 27 March, 09:00-10:30 | H-U2 ENCePP and eHRs EUROPEAN COMMISSION’S eHEALTH ACTION PLAN 2012-2020 Peter Arlett, Pharmacovigilance Department, European Medicines Agency, EU Session Chair: Terje Peetso, Policy Officer, Unit H1 - Health and wellbeing, Directorate Tracing Adverse Drug Reactions (ADRs) to eHR – Bridging the General Communications Networks, Content and Technology (DG CONNECT), interoperability gap European Commission, EU Ola Strandberg, Chief Product Officer, Uppsala Monitoring Center, Sweden
The ‘eHealth Action Plan 2012- 2020, Innovative Healthcare for the 21st Century’ Big Data: The promise and challenge for personalised medicine aims at utilising eHealth to address current healthcare challenges. The activities Joel Haspel, Director Healthcare Strategy, Oracle Health Sciences, UK can be largely divided into four groups: 1. Achieve wider interoperability in eHealth services; 2. Support research, development, innovation and competitiveness in eHealth; 3. Facilitate uptake and ensure wider deployment of eHealth and 4. Promote policy dialogue and international cooperation theme 8| THEME 9 33
Session 0808 | Thursday, 27 March, 16:00-17:30 | H-U2 Session 0902 | Wednesday, 26 March, 11:00-12:30 | 5AB-O1
THE ROLE OF SOCIAL MEDIA IN HEALTHCARE PATIENT EMPOWERMENT: OPPORTUNITIES AND CHALLENGES Session Chair: Session Chair: Hans van Bruggen, Director, eCTDConsultancy, the Netherlands Gerard Nguyen, Hôpital Avicenne Aphp/Rett Syndrome Europe, France
Social media typically consists of four characteristics that have changed the Six Proven Strategies to Advocacy Engagement for Clinical Trials nature of interactions among people and organisations: user generated content, Aaron Fleishman, Social Innovation, BBK Worldwide, USA community, rapid distribution, and open, two-way dialogue. This change in the Focus on the Patient: An industry players' perspective on collaboration and nature of the interactions does not only impact the communication in people’s patient empowerment social life, but also the communication between patients and healthcare Kay Warner, Project Manager "Focus on the Patient", Global Medical Platforms providers and between healthcare providers and industry. & Capabilities, GlaxoSmithKline, UK This session focuses on the patients view on social media in healthcare, as well as the role of the users in the development of social media and its impact on Patient Viewpoint on Patient Empowerment: Concepts, misconception, use industry. and misuse Gerard Nguyen, Hôpital Avicenne Aphp/Rett Syndrome Europe, France Patient View on the Role of Social Media in Healthcare Marco Greco, President, European Federation of Crohn's and Ulcerative Colitis Session 0904 | Wednesday, 26 March, 16:00-17:30 | 5AB-O1 Associations (EFCCA), Board Member, European Patients' Forum, Belgium EFFICIENT USE OF SOCIAL MEDIA TO WORK WITH e-PATIENTS Session Chair: Better Targeting Patients Using Social Media Andre Briola, Strategic Consultant, BBK Worldwide, USA Mikkel Arnoldi Pedersen, Global Head, Vertic Healthcare, Denmark Patient-Centric Engagement in Clinical Trials and the Digital Age Social Media – Changing landscape and impact Kai Langel, Principal Consultant, eClinical Health, Belgium Murali Parthasarathy, Managing Director, Saaraa Medical Solutions, USA Collaborating with Patient Organisations via Social Media to Optimise Drug Theme 9 | Involving and Informing Patients Development Stella Stergiopoulos, Tufts Center for the Study of Drug Development, USA Jan Geissler, Project Director EUPATI The Power of Patient-Driven Communities and their Role in Research: The Well informed patients and patient advocates have a key role to play in the RareConnect example implementation of patient-centred clinical research strategies and approval Rob Pleticha, RareConnect Project Manager, EURORDIS, France processes, access to treatments and treatment optimisation approaches. In an era of growing demand and emphasis on both quality and sustainability of healthcare, it is critical to involve patients in the R&D process.
In many disease areas, patients are already actively engaging in the many processes involved in the development of new treatments today - from Just Announced! contributing to protocol design, informed consent and ethical review to the overall medicines development process, marketing authorisation and Clinical Trials Workshop II − Translating healthcare policy. Involving patients can accelerate research and make it more effective. the New Transparency Requirements
This theme will look into examples of what patients need to know about clinical into Practice trials, how to turn informed consent into an opportunity, best practice how patient advocates are involved in clinical research today, how to effectively Event #14116 use social media and mobile devices to work with patients, and how to train 24-25 September 2014 patient advocates to be knowledgeable partners in clinical research. Millennium Gloucester Hotel London Kensington, UK
Session 0901 | Wednesday, 26 March, 09:00-10:30 | 5AB-O1
PATIENTS AS PARTNERS IN CLINICAL RESEARCH Session Chair: Jan Geissler, EUPATI, Leukemia Patient Advocates Foundation
Increasing Health Literacy and Making Doctor-Patient Communication More Effective Kay Parkinson, Chief Executive Officer, Alstrom Syndrome, UK
Communicating Clinical Trials: Combining regulatory obligations and pa- tient recruitment Holger Maria Rohde, Director, Strategy Implementation Lead, Strategy and Business Operations Global R&D, Merck Serono, Germany
Empowering and Educating Patients in Medicines R&D Maria Mavris, Director Therapeutic Development, EURORDIS, France
Panel with Melanie Carr, Head of Small and Medium-sized Enterprise Office, Stakeholders and Communication Division, European Medicines Agency, EU 34 THEME 10
Theme 10 | Globalisation/Inspections Herding a Flock – Global adverse event submission Estelle Michael, Senior Director, Policy and Intelligence, Europe and Martin Henzl, Director, Pharmacovigilance Technology, Baxter, Austria International Regulatory Policy, Intelligence, AstraZeneca, UK Lembit Rägo, Coordinator, Quality Assurance and Safety for Medicines, Session 1003 | Wednesday, 26 March, 14:00-15:30 | LM-O1 Essential Medicines and Health Products, WHO, Switzerland GLOBAL DEVELOPMENT AND SUPPLY Session Chair: Globalisation continues to grow and evolve in a number of areas of interest Frédéric Bourgeois, AVP, Global Quality Supply Chain, Sanofi, France to the pharmaceutical industry. Indeed, if time permitted, a whole conference could be dedicated to this topic! In lieu of such luxury the focus of this theme This session will look at complexities in the supply chain from both a regulatory will be: and Quality/GMP perspective with examples and case studies. Then we will • Regulatory harmonisation initiatives – from EU accession to global explore the potential link between supply chain issues and drug shortages. networking • Market access – regulatory and cultural challenges and opportunities, e.g. Effects of Complex Supply Chains on the Regulatory Strategy for Emerging impact of new science on concepts such as ethnicity Markets • Challenges of developing global regulatory strategies in light of innovation Kirsten Jacobs, Head of Regulatory Submissions/Operations, Pharmalex, and emerging diseases Germany • Managing and working around complexity of supply chain in face of Supply Shortages of Medicines in Europe: Patient perspective increasing regulatory scrutiny David Haerry, European AIDS Treatment Group (EATG) and co-chair of the • Mutual recognition and sharing of resource, particularly with regard to GxP Patients' and Consumers' Working Party at the EMA, Switzerland inspections • Future regulatory framework – what will the landscape look like 10-20 years Quality/GMP Perspective on Supply Chain Issues – European generic from now? medicines industry view Gerd Fischer, Head Operations Regulatory Intelligence, Boehinger-Ingelheim, Session 1001 | Wednesday, 26 March, 09:00-10:30 | LM-O1 Germany Julie Marechal-Jamil, Senior Manager Quality & Regulatory Affairs, European REGULATORY HARMONISATION AND REGULATORY CONVERGANCE - Generic Medicines Association (EGA), Belgium AN UPDATE Session Chair: Session 1004 | Wednesday, 26 March, 16:00-17:30 | LM-O1 Lembit Rägo, Coordinator, Quality Assurance and Safety for Medicines, GCP INSPECTIONS – INTERNATIONAL COLLABORATION AND Essential Medicines and Health Products, WHO, Switzerland HARMONISATION EFFORTS Regulatory harmonisation and convergence initiatives continue to be very Session Chair: active throughout the globe. In this session, we have brought together speakers Ana Rodriguez, Head of Clinical and Non-clinical Compliance, European who are able to provide experience from different regions and perspectives. Medicines Agency, EU
Current Status and Challenges of Bilateral/Multilateral Meetings Clinical trials increasingly occur on a global scale, with significant growth of Junko Sato, PMDA International Liaison Officer at EMA, UK activity in so-called emerging economies. This change in location of clinical development activities has numerous implications not only for the patients Experience of Accession and health care providers but also for the sponsors of those trials and the Viola Macolic Sarinic, Head of Agency, Agency for Medicinal Products and regulatory agencies around the globe responsible for their supervision. Medical Devices (HALMED), Croatia There is growing concern both among regulators and in public debate, about how well these trials are conducted from an ethical and scientific/ Regulatory Harmonisation and Convergence – An Update from Low- and organisational standpoint (including GCP compliance) and about the available Middle-Income Countries framework for the supervision of these trials. Initiatives in reaching a common Murray Lumpkin, Senior Fellow, Regulatory Affairs, Global Health and understanding and framework for ethical and scientific standards, achieving Integrated Development Bill and Melinda Gates Foundation, USA a strong regulatory and ethical framework in all countries where clinical trials are conducted, sharing of expertise and delivery capacity in these emerging Session 1002 | Wednesday, 26 March, 11:00-12:30 | LM-O1 economies, increasing the number of third country GCP inspections and the SURVIVING SAFETY AND QUALITY INSPECTIONS IN THE ERA OF need to improve the international collaboration on GCP inspections will be GLOBALISATION: HARMONISING SYSTEMS AND PROCESSES ACROSS reviewed during this session. COMPANY UNITS Session Chair: Regulator’s Experience of GCP Inspection Conducted Including in Emerging Ambrish Mathur, Vice President, Strategic Development, Aris Global, USA Markets Gunnar Danielsson, Senior Expert, Pharmaceutical Inspector, Medical Products With the global market reach of most large pharma companies, together with Agency (MPA), Sweden their widely distributed business and manufacturing centres, companies are challenged with implementing efficient workflows and quality processes that Industry Perspective/Experience on GCP Inspection ensure global regulatory compliance and inspection readiness. This session Kristel Van De Voorde, Director WW Regulatory Compliance-Europe, looks at case studies from large pharma on implementing processes for Bristol-Myers Squibb International, Belgium monitoring and ensuring compliance with safety submissions globally. Current GCP Collaboration/Harmonisation Activities Surviving Safety and Quality Inspections in the Era of Globalisation: Har- Ernesto Vera, Head of Sector, Good Clinical Practice and PhV Inspection Area, monising systems and processes across company units Spanish Agency of Medicines and Medical Devices (AEMPS), Spain Ambrish Mathur, Vice President, Strategic Development, Aris Global, USA
Achieving Excellence in Pharmacovigilance Inspection Preparedness for Global Environments Colleen Walsh, Head of Operational Excellence and Compliance, Safety and Benefit Risk Management, Biogen Idec, USA theme 10 35
Session 1005 | Thursday, 27 March, 09:00-10:30 | LM-O1 Update from Thailand Yuppadee Javroongrit, Senior Expert in Pharmaceuticals Standard, Thai Food GLOBAL SUBMISSION AND REVIEW STRATEGY - HOW RAPIDLY and Drug Administration, Thailand INNOVATION CAN REACH GLOBAL MARKETS Session Chair: Update from Korea Joseph Scheeren, Senior Vice President, Head of Global Regulatory Affairs & Moo-Young Yoo, Director General, Ministry of food and Drug Safety (MFDS), Site Head of Global Development, Bayer Healthcare Company Ltd, China Korea
This session will discuss how to optimise global regulatory submissions Update from China and review for timely patient access to innovative medicines as well as the Jinhai Qiu, Division Chief, China Food and Drug Administration (CFDA), China challenges beyond (ICH) harmonisation. Update from Japan Perspective from Regulator: Good review practice Hiroshi Yamamoto, Chief Safety Officer, Pharmaceuticals and Medical Devices Petra Dörr, Head of Management Services and Networking, Swissmedic, Agency (PMDA), Japan Switzerland Session 1008 | Thursday, 27 March, 16:00-17:30 | LM-O1 Achieving Convergence in Global Regulatory Approvals and Market Access for True Innovation REGULATORY SIMPLIFICATION: VISION, OXYMORON, OR ‘MISSION Alberto Grignolo, Corporate Vice President, Global Strategy, PAREXEL IMPOSSIBLE’? Consulting, USA Session Chair: Markus Hartmann, Principal Consultant, European Consulting & Contracting in Perspective from Industry: How to develop and manage global regulatory Oncology, Germany submission, from pre-filing strategy to handling multiple, cross-regional questions from authorities during assessment Regulatory simplification is more than a buzzword: it reflects concerns from Pascale Vintezou, Associate Vice-President, Global Regulatory Affairs – many stakeholders that future clinical R&D will face serious problems if no Intercontinental Region Head, Sanofi, France adequate equilibrium between best-harmonised public supervision and self- regulation can be established. This session will look at how new forms of and Panel with Jordi Llinares, Head of Product Development Scientific Support, initiatives for self-regulation could contribute to a future, simplified regulatory European Medicines Agency, EU framework urgently required for the efficient conduct of global clinical trials.
Session 1006 | Thursday, 27 March, 11:00-12:30 | LM-O1 Heteronomy versus Autonomy: The normative context for regulatory sim- plification PANEL DISCUSSION: REGULATION 2025 – STAKEHOLDER VISION FOR THE Nicola Stingelin, Ethics Expert to the European Commission, Basel University FUTURE OF THE GLOBAL REGULATORY FRAMEWORK BETWEEN NOW Hospital, Institute for Biomedical Ethics, Switzerland AND 2025 Session Chair: Self-Regulation in the Clinical Development Process: Pros and cons. An Richard Barker, Director, Centre for the Advancement of Sustainable Medical industry perspective Innovation (CASMI), UK Nick Sykes, Senior Director, Worldwide Safety and Regulatory, Pfizer, UK
This session will feature a discussion around the potential future regulatory Alliance for Clinical Research Excellence and Safety (ACRES): An initiative landscape with a panel of experts, who have a range of perspectives on the to build a globally shared system infrastructure for clinical research based topic. Challenging questions will be debated, such as ‘Will we move to a single on standardised operating policies global Regulatory Agency in the future and if so, by when and where will it be Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA located?’ Regulatory Science, UK
Lembit Rägo, Coordinator, Quality Assurance and Safety for Medicines, Essential Medicines and Health Products, WHO, Switzerland Joint DIA/ICOS Conference & Exhibition on Moira Daniels, Vice President, Global Head, Patient Safety Services, Parexel, UK Cardiac Toxicity Resulting from Cancer Chemotherapy: Strategies for Early Detection, Risk Sarah Garner, National Institute for Health and Care Excellence (NICE), UK Mitigation and Clinical Prevention Murray Lumpkin, Senior Fellow, Regulatory Affairs, Global Health and Integrated Development Bill and Melinda Gates Foundation, USA Event #14108 9-10 October 2014 Neil McAuslane, Centre for Innovation in Regulatory Science (CIRS), UK Dorint Hotel Don Giovanni Prague
Session 1007 | Thursday, 27 March, 14:00-15:30 | LM-O1
CURRENT STATUS AND FUTURE CHALLENGES OF ASIAN REGULATORY ENVIRONMENT Session Chair: Nobumasa Nakashima, Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The Asian region is becoming a pharmaceutical manufacturing hub as well as a key market. This session will clarify current issues and discuss future direction in promoting regulatory harmonisation in Asia, focusing on ICH, APEC and ASEAN. 36 THEME 11 | THEME 12
Theme 11 | Regulation of Medical Devices and Session 1108 | Thursday, 27 March, 16:00-17:30 | I-U2 Combination Products CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES AND COMBINATION Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and PRODUCTS Scientific Communication, Switzerland Session Chair: Ilona Reischl, Senior Assessor, Austrian Medicines and Medical Devices Agency This theme will outline major changes in the forthcoming EU Regulations on (AGES), Austria medical devices and IVDs and how they impact drug/device combination products and companion diagnostics. It will also describe what to expect from Clinical investigations of medical devices and combination products will be the regulators and notified bodies when applying for and conducting clinical trials focus of this session. Regulatory and scientific requirements will be presented for combination products. Further, this theme aims to shed some clarity on and discussed, with particular emphasis on specific issues at the intersection the rules as well as to look at the latest IT-based method of communicating of the medicinal product and medical device frameworks. instructions for use to users. Notified Body’s Requirements for Clinical Investigations for Devices and Combination Products Tina Amini, Pharmaceutical Expert, Device/Drug Combination Products, BSI Session 1106 | Thursday, 27 March, 11:00-12:30 | I-U2 Group, UK THE NEW REGULATORY OUTLOOK FOR DEVICES, IVDs AND COMBINATION PRODUCTS Authority’s Requirements for Clinical Investigations for Medical Devices and Session Chair: Combination Products Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Ilona Reischl, Head of Division, Austrian Medicines and Medical Devices Scientific Communication, Switzerland Agency (AGES), Austria
This session will outline major changes in the forthcoming EU regulations on Post-Marketing Studies with Medical Devices in Europe medical devices and IVDs and how they impact drug/device combination Vytis Jusevicius, Project Director, Aptiv Solutions, Switzerland products and companion diagnostics. It will summarise the latest developments at a critical time in the history of medical device regulation. Theme 12 | Pharmaceutical Quality in the 21st Forthcoming Major Changes to the New EU Medical Device Regulation Erik Hansson, Deputy Head of Unit, Health and Consumers Directorate General Century European Commission, EU Graham Cook, Senior Director, Global Quality Strategy, Pfizer, UK
How the Regulation of Drug/Device Combinations will Change under the What are the quality-CMC initiatives that will improve the delivery of medicines New Medical Device Regulation to patients? Are we at a crossroads on the journey for the adoption of the New Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Quality Paradigm, also known as Quality-by-Design (QbD)? The opportunities Scientific Communication, Switzerland to enhance quality approaches in pharmaceutical/biopharmaceutical Notified Bodies' Perspective on the Revision of Medtech Regulation development and manufacturing across the product lifecycle, and support Theresa Jeary, Technical Manager- Medical Devices, LRQA, UK them through the EU and global regulatory framework, will be explored by considering some current hot topics and future challenges for pharmaceutical Session 1107 | Thursday, 27 March, 14:00-15:30 | I-U2 quality in the 21st century.
KEY CONSIDERATIONS FOR DEVELOPMENT AND APPROVAL OF COMPAN- ION DIAGNOSTICS Session 1205 | Thursday, 27 March, 09:00-10:30 | K-U2 Session Chair: Shuna Mason, Partner, Head of Regulatory, CMS Cameron McKenna LLP, UK QUALITY BY DESIGN (QBD) AND INNOVATION IN DEVELOPMENT AND MANUFACTURING An overview of the current and prospective EU regulatory frameworks for Session Chair: companion diagnostics including CE marking requirements and the parties Graham Cook, Senior Director, Global Quality Strategy, Pfizer, UK and regulatory authorities involved. The session will include analysis of the significance of the proposed changes for manufacturers of companion Are we at a crossroads on the journey for the adoption of the New Quality diagnostics and associated pharmaceutical companies looking at the EU legal Paradigm, also known as Quality by Design (QbD)? This session will examine and patient access frameworks and challenges. The “regulator’s” perspective the current progress and challenges with the adoption of QbD in Europe and will also be covered in the form of a notified body’s view of the likely impact Japan and explore next steps from industry and regulatory perspectives. of the new regulatory framework upon the relationship between companion QbD Approach and Regulatory Challenges in Japan diagnostics manufacturers and their notified bodies. Yoshihiro Matsuda, Deputy Director, Division of Pharmacopeia and Standards for Drugs, Office of Standards and Guidelines Development, Pharmaceuticals Development of EU Regulatory Framework for Companion Diagnostics and Medical Devices Agency (PMDA), Japan Shuna Mason, Partner, Head of Regulatory, CMS Cameron McKenna LLP, UK QbD approach and Regulatory Challenges in Europe Companion Diagnostics - A Notified Body’s view Peter Richardson, Head of Quality, European Medicines Agency, EU Sue Spencer, Head of In-Vitro Diagnostic Notified Body, BSI Group, UK QbD: Where next? – Industry experience and perspective Patient Access Challenges for Companion Diagnostics Frank Montgomery, Regulatory CMC Director and Group Manager, AstraZeneca, Markus Bücheler, Institute for Social Medicine, Epidemiology, and Health UK Economics, Charité - Universitätsmedizin Berlin, Germany Panel discussion theme 12 | theme 13 37
Session 1206 | Thursday, 27 March, 11:00-12:30 | K-U2 Theme 13 | The Role of Transparency and Ethics: EXPERIENCE WITH IMPLEMENTATION OF THE LIFECYCLE APPROACH Legal perspectives Session Chair: Geneviève Michaux, of Counsel, Hunton & Williams Belgium Michael James, Director of CMC Regulatory Advocacy, Policy and Intelligence, Christopher Foreman, Senior Director- Legal Affairs, Merck Sharp and Dohme Global Regulatory Affairs, GlaxoSmithKline R&D, UK (Europe), Belgium
Opportunities from the Variations Regulations The theme is dedicated to ‘hot’ legal topics, in particular disclosure of data Speaker invited - please see EuroMeeting Extra for updates by regulators. The first session will generally discuss transparency. Why must data be disclosed and are the current disclosure obligations suited to that Experiences with the Review/Approval of Post-Approval Protocols in objective? The second and third sessions examine in more detail disclosure of Vaccines/Biopharmaceuticals clinical data and safety data. Both categories of data are important but they Mats Welin, Pharmaceutical Assessor, Medical Products Ageny (MPA), raise different issues and carry different risks. The fourth session analyses Sweden the possible impact of data disclosure on patentability, approval of medicinal Industry Experiences with Post-Approval Protocols products outside of Europe and publication in medical journals as well as the Markus Goese, Technical (CMC) Regulatory Manager EU Health Authority safeguards needed to avoid such negative impacts. The fifth session concerns Policy, F. Hoffmann-La Roche, Switzerland transparency of payments made by pharmaceutical and medical devices companies to the healthcare sector. European ‘Sunshine’ will change how the Panel discussion health industry interacts with the healthcare sector. The sixth session examines early access to medicinal products, through compassionate use or named Session 1208 | Thursday, 27 March, 16:00-17:30 | K-U2 patient programmes or due to off-label uses. The seventh session discusses product liability in relation to off-label use and the content of the patient CHALLENGES AND OPPORTUNITIES FOR PHARMACEUTICAL QUALITY information leaflet. Session Chair: Gerd Fischer, Head Operations Regulatory Intelligence, Boehinger-Ingelheim, Germany Session 1301 | Wednesday, 26 March, 09:00-10:30 | F2-OE
After a decade with multiple iniatives and the advancement of science- and TRANSPARENCY – IS CLEARING THE PAST CLOUDING THE FUTURE? risk based quality concepts, where sdoes the pharmaceutical sector stand Session Chair: today, and what are the new challenges and opportunities ahead? The session Christopher Foreman, Senior Director- Legal Affairs, Merck Sharp and Dohme will stimulate discussion on what these challenges and opportunities are and (Europe), Belgium offer perspectives on how these could potentially be addressed. This session will set the scene for the Theme’s topic of Transparency. Why Assuring Quality in a Global and Multicultural Environment must data be disclosed by regulators and are the current disclosure obligations Gerald W Heddell, Director, Inspection Enforcement & Standards Division, suited for that objective? Medicines and Healthcare products Regulatory Agency (MHRA), UK The Transparency Imperative: A boon for drug development and for public Challenges of the Globalisation of Supply Chains for Manufacturing and health Impact on Quality Guido Rasi, Executive Director, European Medicines Agency, EU Georges L. France, Head QA & Compliance, EU Region, Novartis Consumer Health Services SA, Switzerland Transparency on the Level of Clinical Trials Data - The perspective of a National Competent Authority Thomas Lang, Biostatistician, Senior Assessor, Austrian Medicines and Medical Devices Agency (AGES), Austria
Benefit from Do the Current Proposals by Regulators Meet the Objective of Transparency? An Industry Perspective Richard Bergström, Director General, European Federation of Pharmaceutical, DIA Membership Industries and Associations (EFPIA), Belgium
Regulator invited • Professional Development • Knowledge Resources Session 1302 | Wednesday, 26 March, 11:00-12:30 | F2-OE • Networking DISCLOSURE OF CLINICAL TRIAL DATA - WHAT DOES THE FUTURE HOLD? Session Chair: • Volunteer Leadership Peter Bogaert, Partner, Covington & Burling LLP, Belgium This session will review the legal principles that govern the release of clinical For more information, please visit the trial data to third parties, such as researchers but also the public in general. Members Lounge or the DIA Booth The principles governing reactive and proactive will be discussed, as well as the latest status of the litigation before the EU courts and the new Clinical Trials Regulation and its potential impact on transparency.
A View from a National Regulator on the Legal Debate Concerning Access to Clinical Trial Data Diederick Slijkerman, Head of Policy, Governance & Regulatory Affairs, Medicines Evaluation Board (MEB), the Netherlands 38 THEME 13
Industry View on the Legal Aspects of Access to Clinical Trial Data Session 1305 | Thursday, 27 March, 09:00-10:30 | F2-OE Victoria Kitcatt, Assistant General Counsel, European Regulatory Law, Pfizer, TRANSPARENCY OF PAYMENTS TO THE HEALTHCARE SECTOR UK Session Chair: Update on the Legal Situation and Pending Cases before the EU Court Samantha Regenthal, Head Legal & Compliance Management Services, Peter Bogaert, Partner, Covington & Burling LLP, Belgium Attorney at Law, SFL Regulatory Affairs & Scientific Communication, Switzerland
Session 1303 | Wednesday, 26 March, 14:00-15:30 | F2-OE In this session we aim to discuss the rules on transparency of payments / EARLY ACCESS TO UNAUTHORISED MEDICINES benefits to the healthcare sector (healthcare professionals, hospitals, health Session Chair: institutions etc.) made by pharmaceutical companies and their implementation Koosje Van Lessen Kloeke, Life Sciences Lawyer – Partner, Leijnse Artz, the as well as practical impact on companies. Netherlands Transparency in Payments to Healthcare Professionals and Institutions – Recent examples from daily practice, media coverage and case-law give Introduction rise to interesting ethical and legal questions related to access to medicinal Samantha Regenthal, Head Legal & Compliance Management Services, Attorney products that are not (yet) authorised or undergoing clinical trials. As a at Law, SFL Regulatory Affairs & Scientific Communication, Switzerland general rule, a medicinal product may be placed on the market only when it The New EFPIA Disclosure Code – Background and purpose has been authorised after an evaluation of its safety and efficacy. However, Richard Bergström, Director General, European Federation of Pharmaceutical, EU law provides for certain derogations from that rule, for example for Industries and Associations (EFPIA), Belgium investigational medicinal products, named patient and compassionate use. This gives rise to diverging national practices as member states set different Disclosure Requirements – Local implementation and impact on companies requirements. This session will discuss the situation before and after marketing Patricia Lanssiers, Senior Director, Ethics and Compliance Officer for Europe, authorisation, and the situation between marketing authorisation and launch Australia and Canada , S.A. Eli Lilly Benelux N.V, Belgium from different perspectives. Speakers will address the national practices in the EU regarding (post-study) access to investigational products, named patient Session 1306 | Thursday, 27 March, 11:00-12:30 | F2-OE supply, compassionate use and off-label use. Questions to be addressed DISCLOSURE OF SAFETY DATA: CAN PRAC, PATIENTS AND INDUSTRY are e.g. How to balance the interests of the parties involved (individual vs. PERSPECTIVES BE RECONCILED? group of patients, doctors, competent authorities, industry)? What about Session Chair: funding and reimbursement? Can doctors and/or pharmaceutical companies Joyce Ter Heerdt, Assistant General Counsel, Johnson & Johnson, Belgium be (legally) obliged to supply unauthorised products for free? Should a reimbursement authority or healthcare insurer be allowed to promote the use PRAC’s Perspective of an unauthorised (indication of a) product over the use of the authorised June Raine, Chair PRAC, Vigilance and Risk Management of Medicines Division, product? What are the rules and limitations with regard to communication MHRA, UK about early access and off-label use? Industry Challenges in Managing Safety Referral Procedures, Managing the Setting the Scene: The basic EU law principles, the recently revised post-trial Impact in Europe provisions in the Declaration of Helsinki, and practical examples of issues Sarah Montagne, Head EU Regulatory Policy/Head UK Regulatory Affairs, Koosje Van Lessen Kloeke, Life Sciences Lawyer – Partner, Leijnse Artz, Bayer plc, UK the Netherlands Patient Perspective Making the Patchwork More Transparent: A comparison between national Marco Greco, President, European Federation of Crohn's and Ulcerative practices regarding (post-study) access to investigational products, named Colitis Associations (EFCCA), PRAC Patient Representative (alternate), Board patient supply and compassionate use Member, European Patients' Forum, Belgium Cristiana Spontoni, Partner - Head of the European Life Sciences Group, Squire
Sanders, LLP, UK Session 1307 | Thursday, 27 March, 14:00-15:30 | F2-OE Making the Patchwork More Transparent: A comparison between national PRODUCT LIABILITY, OFF-LABEL USE AND PATIENT INFORMATION practices regarding off-label use LEAFLETS Eveline Van Keymeulen, Advocaat (lawyer), Allen & Overy LLP, France Session Chair:
Karina Hellbert, Partner, Fiebinger Polak Leon & Partner, Austria Session 1304 | Wednesday, 26 March, 16:00-17:30 | F2-OE The patient has a right to be transparently informed about the risks associated UNINTENDED IMPLICATIONS OF TRANSPARENCY: PATENTABILITY, USE OF with taking medicinal products. The session deals with liability issues if such COMPETITORS BY EX-EU AND MEDICAL JOURNALS information is not provided, for instance because the product is not provided Session Chair: for such use, is wrongly given or is simply not known at the time when the Lenita Lindström-Gommers, Senior Policy Officer, European Commission actual damage occurred. Health and Consumers Directorate-General, EU Product Liability and Off-Label Use Transparency and the Use of Information Submitted to Health Canada Bernd Unterkofler, Office Manager,Federal Office for Safety in Healthcare Adrienne Blanchard, Partner, Intellectual Property Group Norton Rose, (BASG), Legal Service, Austrian Medicines and Medical Devices Agency Canada (AGES), Austria Disclosure of Data by Regulators: Implications for patentability Product Liability and Harmonised Patient Information Leaflet for MRP Sabine Demangue, Lawyer Patent Law, European Patent Office, Germany Products The Effect of the European Medicines Agency's Proposal on the Disclosure Ina Brock, Partner, Hogan Lovells, Germany of an Innovator Company's Regulatory Dossier Data and Clinical Trial Data Are There Circumstances Possible Under Which a Generic Company Could on Publications in Medical Journals be Held for Shortcomings of an Innovator and Vice-Versa, for Instance Due Christian Gluud, Head of Department, Copenhagen Trial Unit, Centre for to PIL? Clinical Intervention Research, Copenhagen University Hospital, Denmark Martin Spatz, General Manager, Ratiopharm-Arzneimittel Vertriebs, Austria theme 14 39
Theme 14 | Innovation in R&D Models The 100,000 Genomes Project and Genomics England Salah-Dine Chibout, Global Head Discovery & Investigative Safety, Global Tim Hubbard, Head of Bioinformatics, Department of Medical & Molecular Head Preclinical Safety Therapeutic Areas, Novartis Pharma, Novartis Genetics, King's College, London, UK Institutes for BioMedical Research, Switzerland Peter Høngaard Andersen, CEO, Høngaard Consulting, Denmark Session 1404 | Wednesday, 26 March, 16:00-17:30 | NO-O1 INNOVATION IN CLINICAL TRIAL DESIGN AND EVALUATION Efficient and commercially attractive innovation is critical for companies to Session Chair: achieve high quality products. Concepts of innovation in various areas and Martin Simán, Director, Design and Interpretation Centre of Excellence, practices of pharmaceutical research, in discovery and safety research, clinical AstraZeneca, Sweden trial design as well as in drug delivery systems, biomarkers and strategies for patient stratification will be addressed. Innovation opportunities through Research on clinical trial design and evaluation needs to be so seamlessly collaborations with single external partners and extending into large public woven into clinical practice, that the delivery of care also is generating new private partnerships will be discussed. knowledge and thus enables innovation. Clinical research will be addressed from the perspective of enhancing study design methodologies and transparency combined with a continuous learning loop to provide the best Session 1402 | Wednesday, 26 March, 11:00-12:30 | NO-O1 personalised patient care possible. INNOVATION THROUGH PUBLIC-PRIVATE PARTNERSHIP The IMI GetReal Consortium: Developing relative effectiveness estimates for COLLABORATIONS medicines in development Session Chair: Sarah Garner, National Institute for Health and Care Excellence (NICE), UK Salah-Dine Chibout, Global Head Discovery & Investigative Safety, Global Head Preclinical Safety Therapeutic Areas, Novartis Pharma, Novartis Institutes for Predictive Analytic Modelling Operational Characteristics at Design and BioMedical Research, Switzerland Monitoring Clinical Trials Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles, UK Modern information and communication technologies are reinforcing and expanding PPPs beyond all previous limitations and boundaries. Together with Common Study Design Language/Syntax the insight that certain innovations are unfeasible without inter-organisational Norbert Bleich, Senior Project Manager Clinical Science, F. Hoffmann-La collaboration today PPP programs hold a great promise. Outcomes of the Roche, Switzerland largest EU PPP program, IMI, will be discussed. In addition, legal, IP and collaboration management aspects within such large scale PPPs will be Gathering and Leveraging Quality-Centric Metadata in Clinical Trials addressed. Aaron Gadberry, Director Software Architecture, DATATRAK International, USA
IMI as a European Flagship to Address Major Health Challenges Session 1405 | Thursday, 27 March, 09:00-10:30 | NO-O1 Michel Goldman, Executive Director, Innovative Medicines Initative (IMI), INNOVATION IN DRUG DELIVERY SYSTEMS AND COMPLIANCE Belgium Session Chair: Kenny Simmen, Johnson & Johnson Pharmaceutical Research & Development, Initiatives and Challenges for Creating Innovative Drugs UK Hideaki Ui, Deputy Division Director, Planning and Coordination Division, OIP, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Innovative drug targeting, topical administration, in situ forming systems as Biomarker Qualification for Drug-Induced Injury to Kidney, Liver and the well as new biomaterials will be discussed. The important role of the patient Vascular System within IMI SAFE-T Project in the development of drug delivery systems to create innovative solutions Thomas Joos, Deputy Managing Director, NMI Natural and Medical Sciences and innovative ways to improve patient compliance with treatments will be Institute at the University of Tübingen, Germany addressed. Oral-Timed Drug Delivery Affords Chronotherapeutic Benefit in Patients US Perspective on Public-Private Partnerships Howard Stevens, Emeritus Professor, University of Strathclyde, Strathclyde Diane Stephenson, Associate Director, CAMD, Critical Path Institute, USA Institute of Pharmacy and Biomedical Sciences, UK
Session 1403 | Wednesday, 26 March, 14:00-15:30 | NO-O1 Novel Drug and Vaccine Delivery Technologies – From the bench to the patient INNOVATION IN BIOMARKERS AND DISEASE STRATIFICATION Henderik W. Frijlink, Department of Pharmaceutical Technology and Session Chair: Biopharmacy, University of Groningen, the Netherlands Chris Chamberlain, Vice President, Experimental Medicine and Diagnostics, UCB Belgium Improvement of Convenience for the Patient by Designing the Delivery Form Lieven Baert, Managing Director, Jalima Pharma, Belgium Genomic and epigenetic biomarkers offer great promise in refining the development and clinical application of new and existing medicines as well as Session 1406 | Thursday, 27 March, 11:00-12:30 | NO-O1 for assessing disease risk. The use and impact of innovative pharmacogenomic biomarkers in several areas of medicine will be addressed with case studies as INNOVATION IN PRE-CLINICAL AND CLINICAL SAFETY SCIENCES well as highlighting the latest advancements in the molecular diagnostics field. Session Chair: Jonathan Moggs, Global Head of Molecular Toxicology, Novartis Institutes for The Right Patient for the Right Trial: Tools for Enriching Patients and Biomedical Research, Novartis, Switzerland Optimising Trial Design Diane Stephenson, Associate Director, CAMD, Critical Path Institute, USA The poor prediction of toxicity during early drug development is a major challenge to bringing more effective medicines to patients. Key opportunities Molecular Taxonomy and Immune-Inflammation - Preparing for precision for enhancing safety sciences include improved characterisation of molecular, medicine biochemical and cellular pathways of toxicity, together with the development Chris Chamberlain, Vice President, Experimental Medicine and Diagnostics, UCB Belgium 40 THEME 14 | THEME 15 of predictive tools, models and translational safety biomarkers that allow Theme 15 | New and Known Substances - How to fit discovery researchers and clinicians to anticipate and mitigate safety issues. A the rules to needs safe harbor approach for amassing preclinical/clinical safety data and exploring Vesna Koblar, Director, Pharmaceutical Regulatory Affairs Consulting and chemotype-toxicity relationships is essential for an improved information flow Education (raPHARM), Slovenia between bedside and bench. Kristin Raudsepp, Director General of State Agency for Medicines, Estonia
Safety Assessment of Advanced Therapies EU pharmaceutical legislation follows the understanding that the extent of Janis Ancans, EMA Committee for Advanced Therapies, Laboratory of regulatory burden is to be linked to the risk associated with use of medicinal Bioanalytical and Biodosimetry Methods, Faculty of Biology, University of product. Medicines with known active substances have a more advanced Latvia, Latvia safety profile due to more informational input. Regulatory optimisation is possible in this highly regulated area only if based on risk-informed decisions. Predictability of Non-Clinical Safety Models, Present and Future in Debate Beatriz Silva Lima, Professor of Pharmacology at University of Lisbon, Portugal Four sessions offer different views on the understanding of a known active substance, advantages and disadvantages, particularly for biosimilars, Novel Insight into Drug Hypersensitivity Mechanisms through Integration of discussion on possible regulatory optimisation, and on risk management from Immunogenetics, Metabolism, Biochemistry and Preclinical Models the point of view of different interest groups as well as possible impact of new Kevin Park, MRC Centre for Drug Safety Science, University of Liverpool, UK directive on falsified medicines on accessibility of medicines with known active substances. Session 1407 | Thursday, 27 March, 14:00-15:30 | NO-O1
NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR Session 1505 | Thursday, 27 March, 09:00-10:30 | 5AB-O1 MONOCLONAL ANTIBODIES NEW ACTIVE SUBSTANCES AND KNOWN ACTIVE SUBSTANCES – Session Co-Chairs: DESIGNATION, IMPLICATIONS Guenter Waxenecker, Expert Biologics, Austrian Medicines and Medical Session Chair: Devices Agency (AGES), Austria Carla Schoonderbeek, Partner, Hoyng Monegier LLP, the Netherlands Peter Høngaard Andersen, CEO, Høngaard Consulting, Denmark The subject for the session is Regulatory Data Protection (RDP) for New Active This session will provide a reflection on the need for innovative methods for Substances (NAS), Known Active Substances (KAS) and combination products. non-clinical assessment of biosimilar monoclonal antibodies from a regulators As these issues usually concern matters of both law and science, the session and industry perspective and will finally give a view on globalised development will focus both on the application of the law and the application of the relevant strategies. scientific tests. The session aims to address the issues from a legal, regulatory and public policy perspective in an interactive manner. The speakers will make Non-Clinical Development Paradigms for Biosimilar Monoclonal Antibodies presentations focusing on the relevant legal provisions as well as the guidance, from a Regulators Perspective application in practice and as yet unresolved issues. This will be followed by a Guenter Waxenecker, Expert Biologics, Austrian Medicines and Medical panel discussion between the audience and the speakers. Devices Agency (AGES), Austria NAS: Designation and Consequences (legal aspects) The Role of Functional Bioessays in the Assessment of Similarity Carla Schoonderbeek, Partner, Hoyng Monegier LLP, the Netherlands Cornelius Fritsch, Fellow, Novartis, Switzerland NAS: Designation and Consequences (regulatory aspects) Henk Schuring, Group Vice President Regulatory Affairs - Europe , Genzyme Non-clinical Development of Biosimilar Monoclonal Antibodies: Europe B.V., the Netherlands A science-based approach in a global environment Jennifer Sims, President, Integrated Biologix, Switzerland KAS: Fresh Periods of RDP for Known Active Substances and RDP for Combination Products Session 1408 | Thursday, 27 March, 16:00-17:30 | NO-O1 Barbara Lange, Senior Regulatory Legal Counsel, Novartis, Switzerland PHARMA INDUSTRY INCENTIVE SYSTEMS Session Co-Chairs: Decision Makers and Unresolved Issues Peter Høngaard Andersen, CEO, Høngaard Consulting, Denmark Lidia Retkowska-Mika, Director, Legal Department, Office for Registration of Salah-Dine Chibout, Global Head Discovery & Investigative Safety, Global Head Medicinal Products, Medical Devices and Biocides, Poland Preclinical Safety Therapeutic Areas, Novartis Pharma, Novartis Institutes for BioMedical Research, Switzerland Session 1506 | Thursday, 27 March, 11:00-12:30 | 5AB-O1 HOW TO REALISE BIOSIMILARS’ FULL POTENTIAL Session Chair: Science brings us towards a world of personalised medicines. However, current Sundar Ramanan, Strategic Planning & Operations Director, R&D, Amgen, USA incentive systems punish companies targeting specific patient groups enriched with responders and thus prevent translation of science to medical innovation. The increasing uptake of existing biosimilars has generated considerable interest and debate about the future potential of the biosimilars space but despite the Creating a Future for the Pharma Industry through Innovation Ecosystems widespread optimism, a number of key challenges relating to the known active Wim Vanhaverbeke, Professor Innovation Management & Strategy at the substance remain – pharmacovigilance, naming and traceability – which if not Hasselt University, founder Exnovate, Belgium adequately addressed, can limit the potential of biosimilars before it is fully realised. This session will review these three independent but interlinked challenges, How Close are We to “Targeted” Medicines? providing case studies and examples to illustrate key points and reflect on what Chas Bountra, Chief Scientist, Structural Genomics Consortium, University of needs to be done to ensure the conversation remains focused on patient safety first. Oxford, UK Tajani Report Analysis Are Current Incentive Systems Facilitating the Introduction of Targeted Thomas Heynisch, Deputy Head of Unit, Food and Healthcare Industries, Medicines? Biotechnology, DG Enterprise, European Commission, EU Peter Høngaard Andersen, CEO, Høngaard Consulting, Denmark THEME 15 | THEME 16 41
EGA Point of View Theme 16 | Knowledge Management and Martin Schiestl, Scientific and Regulatory Advisor, Sandoz, Austria Regulatory/Competitive Intelligence EFPIA Point of View Marianne Köhne, EU Regulatory Intelligence Network Group, Global Sundar Ramanan, Strategic Planning & Operations Director, R&D, Amgen, USA Regulatory Affairs, Boehringer Ingelheim, Germany
Regulator’s Point of View Knowledge Management and Regulatory/Competitive Intelligence (RI/CI) are Peter Richardson, Head of Quality, European Medicines Agency, EU disciplines which help manage the flood of information in the rapidly changing regulatory environment and its increasing complexity and transparency in a Session 1507 | Thursday, 27 March, 14:00-15:30 | 5AB-O1 global environment. Adding business value by gathering and analysing this HOW TO OVERCOME THE OBSTACLES IN PATIENTS’ ACCESS information to provide targeted input along the drug development process Session Chair: and into regulatory strategies and decision making is the leading objective Kristin Raudsepp, Director General of State Agency for Medicines, Estonia of an RI function. This goes along with safeguarding regulatory compliance and making efficient use of the increasing amount of regulatory information The session will look at the availability and accessibility of medicinal products. We available on authority websites. RI experts will share their experiences and will try to find out if there is a favourable environment for all stakeholders, especially provide practical examples. patients. The session will explore the possible hurdles for patients’ access to known active substances and look at the ongoing developments to accelerate the start Session 1601 | Wednesday, 26 March, 09:00-10:30 | 6AB-O1 of the marketing of generics in Europe, e.g. new transparency directive. Attention will be paid to the price pressure on generics. The experience will be given about WHAT CAN REGULATORY INTELLIGENCE GROUPS LEARN FROM EXPERTS the implications of the new directive on falsified medicines from the viewpoint of IN KNOWLEDGE MANAGEMENT? access to known active substances. We will discuss if the patent regulation and data Session Chair: exclusivity are fully in the interest of a patient and where the best balance for new Carolyn Hynes, Director, GlaxoSmithKline, UK and known active substances is. We will discuss scientific development, including "repurposing" known products to more targeted populations improving the safety Core functions of regulatory intelligence groups are closely related to the profile or enhancing efficacy. The session will explore the opinions of the industry, process of knowledge management. This session examines current practices of the agency and of patients about known active substances, including biosimilars and tools and novel approaches for future consideration. and interchangeability. Sharing Regulatory Intelligence: Best practices and case studies Off-Patent Medicines - More valuable than ever Carolyn Hynes, Senior Director, Global Regulatory Intelligence, GlaxoSmithKline, Richard Bergström, Director General, European Federation of Pharmaceutical, UK Industries and Associations (EFPIA), Belgium
Does the Current Regulatory Framework Constitute a Threat to a Long-Term Knowledge Management in Regulatory Strategy: The importance of Access to Generic Medicines? Regulatory Intelligence Beata Stepniewska, Deputy Director, Eurpean Genrics Association (EGA), João da Silva Duarte, Regulatory Intelligence & Policy Manager, H. Lundbeck, Belgium France
Partners and Competitors in Ensuring Availability and Access Knowledge Management and Regulatory Intelligence Kristin Raudsepp, Director General,State Agency for Medicines, Estonia Rob Van der Spek, Director Knowledge Management Advisory Services, DNV GL, the Netherlands Panel discussion with Nicole Bedlington, Executive Director, European Patients Forum Session 1602 | Wednesday, 26 March, 11:00-12:30 | 6AB-O1
Session 1508 | Thursday, 27 March, 16:00-17:30 | 5AB-O1 THE PRACTICAL ASPECTS OF THE REGULATORY INTELLIGENCE FUNCTION – ORGANISATION AND PROCESSES RISK PERCEPTION, RISK ACCEPTANCE AND KNOWN ACTIVE SUBSTANCES Session Chair: Session Chair: Linda Bowen, Head of US Regulatory Policy and Intelligence, Sanofi, USA Vesna Koblar, Director, Pharmaceutical Regulatory Affairs Consulting and Education (raPHARM), Slovenia This session will focus on the who, what and how of the Regulatory Intelligence Our decisions, although based on the same safety information on medicines, show function including expected deliverables, measurable metrics, and the active diversity that implies. Our risk perception and risk acceptability differs across the EU role RI plays in influencing the regulatory environment. depending on interested groups, cultural background and tradition. We will discuss the risk perception and risk acceptability from a National Competent Authority How to Successfully Implement and Leverage the Regulatory Intelligence (NCA), a patient and industry point of view and try to find common points of Function understanding of risk acceptance and consequences in practice linked mostly to Marianne Köhne, EU Regulatory Intelligence Network Group, Global medicines with known active substances. Regulatory Affairs, Boehringer Ingelheim, Germany
Risk Perception, Risk Acceptance and Known Active Substances – NCA point The Journey from Consultation to Compliance of view Deborah Henderson, Executive Director, Global Regulatory Policy, Merck, USA Walter Schwerdtfeger, President, Federal Institute for Drugs and Medical Devices (BfArM), Germany Experiences from Building and Maintaining a Regulatory Lessons-Learned Database Patient Awareness of Off-Label Use of Known Active Substances and Risk Åsa Rembratt, Senior Regulatory Intelligence Manager, Novo Nordisk, Denmark Acceptability in Rare Paediatric Diseases Tsveta Schyns-Liharska, PDCO Member, Representative, European Network for Research on Alternating Hemiplegia (ENRAH), Belgium
Benefit-Risk Assessment of Established Substances Hubertus Cranz, Director General, AESGP, Belgium 42 THEME 16 | STAND-ALONE/HOT TOPIC SESSIONS
Session 1603 | Wednesday, 26 March, 14:00-15:30 | 6AB-O1 Stand-Alone/Hot topic sessions REGULATORY INTELLIGENCE INPUT INTO DEVELOPMENT STRATEGIES Session Chair: Session 1704 | Wednesday, 26 March, 16:00-17:30 | H-U2 Christine Mayer-Nicolai, Merck KGaA, Germany THE CASE FOR AND AGAINST A REFORM OF THE PHARMACEUTICAL LEGISLATION This session will provide insights into how regulatory intelligence can provide Session Chair: a deeper understanding and valuable metrics as a sound basis for product David Jefferys, Senior Vice President, Esai Medical Research, UK development and regulatory strategies. Different perspectives of involved parties like the scientific Escher project, a consultant and a pharmaceutical Update on Review of The Escher Project and Emerging Findings company will be presented. Jean Philippe de Jong, Project manager,The Escher Project, the Netherlands
Scientific approach: Regulatory Science and Methods: How to generate Views on Conditional Authorisation - what is possible now and what could be tangible results developed within the existing legislation Jean Philippe de Jong, Project manager,The Escher Project, the Netherlands Christiana Rothkegel, Regulatory Programme Manager, F. Hoffman-La Roche, Switzerland Synergies of Public Affairs and Regulatory Affairs Functions – How to maximise internal coordination and external impact? Meeting the Challenges of Safety Referrals and Hope for the Future Anna Hallersten, Public Affairs Director, SFL Regulatory Affairs & Scientific Sarah Montagne, Head EU Regulatory Policy/Head UK Regulatory Affairs, Communication, Switzerland Bayer plc, UK
Industry Point of View: Regulatory Intelligence input for development and Session 1705 | Thursday, 27 March, 09:00-10:30 | I-U2 regulatory strategy Claire Lavery, Director, Global Regulatory Policy and Intelligence, Janssen THE CHANGING FACE OFTHE EMA – INSIDE AND OUT: AN OVERVIEW OF Research and Development, UK THE NEW STRUCTURE AND EXPECTATIONS FROM THE CHANGES Session Chair: Session 1604 | Wednesday, 26 March, 16:00-17:30 | 6AB-O1 Melanie Carr, Head of Small and Medium-sized Enterprise Office, Stakeholders and Communication Division, European Medicines Agency, EU REGULATORY INTELLIGENCE IN PRACTICE – HOW REGULATORY AUTHORITIES INFORM ABOUT DECISION MAKING In 2013, the EMA embarked on a journey to re-shape the organisation and Session Chair: prepare for the future. The Agency’s internal structure has been re- designed Birgit Wolf, Regulatory Intelligence Manager, Bayer Pharma, Germany to better support the European medicines network and work of the Agency's scientific committees, to better share data held by the Agency, and to better This session will take a look at some of the hidden treasures found on meet the needs of the Agency’s stakeholders. regulatory agency websites as well discussing potential changes regarding provisions of information and how stakeholders can get the most out of what This session will provide an update on the transition to the new structure as is available. We also take a look at differences between agencies and regions well as practical insight into some of the changes which are underway to its (EMA, National Agency, HMA initiatives, US, Canada) and use a case study operating processes, including the reinforced product team concept and what to illustrate different approaches, e.g. with regard to types of information it will mean for applicant companies published on outcome of assessment work. The New EMA Organisation and Beyond - How the new structure will support EMA Perspective the Agency’s vision Melanie Carr, Head of Small and Medium-sized Enterprise Office, Stakeholders Anthony Humphreys, Head of Scientific Committee Support Department, and Communication Division, European Medicines Agency, EU European Medicines Agency, EU
National Agencies View and Harmonisation Initiatives at HMA level Impact of Changes from a Practical Perspective - What will it mean for Truus Janse-de Hoog, former Staff Member European Cluster, Medicines applicant companies Evaluation Board (MEB), the Netherlands Michael Berntgen, Head of Scientific and Regulatory Management Department, European Medicines Agency, EU Transparency and Access to Information in the US and Canada Linda Bowen, Head of US Regulatory Policy and Intelligence Sanofi, USA How Will the Changes Enhance the Work of the EMA’s Scientific Committees Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products Panel with Peter Bachmann, Chair CMDh and Senior Expert, European and Agency (MPA) Sweden International Affairs, BfArM, Germany
THE Training Course to learn The Essentials of European Regulatory Affairs
Extended to two days to cover more topics and kept up to date in minute details by the experienced faculty!
23-24 June 2014 | Amsterdam, the Netherlands STAND-ALONE/HOT TOPIC SESSIONS 43
Stand-Alone/Hot topic sessions Stand-Alone/Hot topic sessions
Session 1706 | Thursday, 27 March, 11:00-12:30 | G-U2 Session 1708 | Thursday, 27 March, 16:00-17:30 | 6AB-O1
JAPANESE REGULATORY SESSION /PMDA UPDATE GCP HOT TOPIC 2 Session Chair: GCP SENIOR EXPERTS’ ROUNDTABLE Nobumasa Nakashima, Director, Office of International Programs, Session Chair: Pharmaceuticals and Medical Devices Agency (PMDA), Japan Beat Widler, Managing Partner, Widler & Schiemann Ltd., Switzerland Gabriele Schwarz, Head GCP Inspectorate, BfArM, Germany The PMDA will explain its current services and the Japanese drug regulation ,and answer questions on these and PMDA’s future initiative / challenges for This session builds on the successful “Inspectors’ Roundtable” session of past faster review and better life cycle management of drugs. EuroMeetings. Inspectors from health authorities and senior representatives from industry will debate challenging questions submitted by participants and Tatsuya Kondo, Pharmaceuticals and Medical Devices Agency, Chief Executive the GCP and QRM DIA Communities. Officer, Japan The panelists will freely represent their personal professional opinions which Taka Yamori, Director or Center for Product Evaluation, Pharmaceuticals and should not be interpreted as being the “official” position of their institutions Medical Devices Agency (PMDA), Japan or companies.
Hiroshi Yamamoto, Chief Safety Officer, Pharmaceuticals and Medical Devices Lisbeth Bregnhøj, Senior GCP Inspector, Danish Health and Medicines Agency, Japan Authority, Denmark Regina Freunscht, Vice President, Global Research & Development Quality Session 1707 | Thursday, 27 March, 14:00-15:30 | 6AB-O1 Assurance, Merck Serono, Germany Alexander Hoenel, Inspections, Austrian Medicines and Medical Devices GCP HOT TOPIC 1 Agency (AGES), Austria THE USE OF ELECTRONIC HEALTH RECORDS BY INVESTIGATORS Ana Rodriguez, Head of Clinical and Non-clinical Compliance, European AND SPONSORS FOR CLINICAL RESEARCH; THE USE OF DATA AND Medicines Agency, EU INTELLIGENCE BY REGULATORY AGENCIES FOR INSPECTION PLANNING Vincent Yeung, GCP Operations Manager and Senior GCP Inspector, MHRA, UK AND THE USE OF AUDIT FINDINGS FOR THE IMPROVEMENT OF STUDY Kristel Van De Voorde, Director WW Regulatory Compliance-Europe, DESIGNS Bristol-Myers Squibb International, Belgium Session Chair: Gabriele Schwarz, Head GCP Inspectorate, BfArM, Germany Session LB01 | Thursday, 27 March, 12:45-13:45 | Room 12-U2
In this session, challenging GCP hot topics will be debated by speakers from Briefing on Advanced Therapy Medicinal Products health authorities, sponsors and other competent parties. With the wider use THE HOSPITAL EXEMPTION FOR ADVANCED THERAPIES: CAN WE BRIDGE of electronic records by physicians, new challenges from a GCP standpoint THE GAP BETWEEN LOCAL TREATMENTS AND PAN-EUROPEAN STAN- have emerged when conducting clinical trials in such clinics. DARDISED THERAPIES? Session Chair: EHR, Similarities and Differences between the European Reflection Paper Matthias Wilken, Hear Regulatory Affairs Europe, German Pharmaceutical and FDA Guidance for Industry on (e)source Industry Association (BPI), Germany Lisbeth Bregnhøj, Senior GCP Inspector, Danish Health and Medicines Authority, Denmark The implementation of the ATMP Regulation (1394/2007), and in particular the application of the so-called Hospital Exemption, proved a matter of debate Risk-Based Inspections – The use of data and intelligence in inspection amongst stakeholders. Whilst the Hospital Exemption delivers innovative and planning customised therapies to individual patients at local level, it is perceived to have Vincent Yeung, GCP Operations Manager and Senior GCP Inspector, MHRA, UK the potential to undermine the development of centrally authorised ATMPs.
What a Commercial Sponsor Could Learn from Audits in Africa of a Non- Although it is still unknown whether the Commission will or will not revise the Commercial Study – Or how audit findings can be “designed into the study” ATMP Regulation, this session will look into possible ways to have a balanced Beat Widler, Managing Partner, Widler & Schiemann Ltd, Switzerland approach to the Hospital Exemption, taking into account patients’ needs, regulatory requirements, and medical Innovation
Regulator’s View th 15 DIA Conference & Exhibition on Paula Salmikangas, Vice-Chair CAT, Senior Researcher, Finnish Medicines European Electronic Document Agency (FIMEA), Finland Management (eDM) Patient’s View Alastair Kent, Genetic Alliance, UK
Event #14110 The Industry’s View 1-3 December 2014 Eduardo Bravo, CEO, Tigenix, Belgium Berlin, Germany Q&A Discussion 44 focus sessions
Focus on Non-Clinical Focus on Biosimilars
Tutorial 5 | Tuesday, 25 March, 09:00-12:30 | 6B-O1 Tutorial 6 | Tuesday, 25 March, 09:00-12:30 | O-O1
NON-CLINICAL SAFETY FOR NON-EXPERTS: WHAT IS IMPORTANT FOR BIOSIMILAR DEVELOPMENT - WHAT ARE THE CURRENT CHALLENGES? YOUR SUBMISSIONS? Primal Kaur, Global Development Director, Amgen, USA Klaus Olejniczak, Non-clinical Regulatory Consultant, Germany Gerd Bode, Lecturer, University of Göttingen, Essen, Lyon, Bonn and This interactive tutorial will provide an overview of the key steps required Consultant, Germany for developing a biosimilar, the differences between biosimilars and non comparable biologics and worldwide guidelines for and regulation of This tutorial identifies the challenges and solutions for integrating all sources biosimilars. It will provide an in-depth understanding of the key principles for of toxicological data involved and helps to understand the non-clinical evaluating biosimilars, and give examples that highlight the importance of development and strategies of drug toxicity or safety assessments. The clinical trials for detecting clinically meaningful differences. The tutorial will international state of the art of non-clinical evaluation of pharmaceuticals, the explain the need for a separate biosimilars pathway to the generics pathway interpretation of toxicological data and the acceptability or unacceptability as well as the importance of unique naming for biosimilars. of toxicological risks (benefit/risk assessments) for pharmaceuticals will be discussed. Tutorials are not included in your registration but can be added for an additional fee. Tutorials are not included in your registration but can be added for an additional fee. Session 0105 | Wednesday, 26 March, 09:00-10:30 | E1-OE
BIOSIMILARS - BUILDING ON EUROPEAN FOUNDATIONS TO ACHIEVE Session 1406 | Wednesday, 26 March, 11:00-12:30 | NO-O1 GLOBAL HARMONISATION INNOVATION IN PRE-CLINICAL AND CLINICAL SAFETY SCIENCES Session Chair: Session Chair: Judith McDonald, Senior Director, Global Regulatory Lead, Pfizer Biosimilars, Jonathan Moggs, Global Head of Molecular Toxicology, Novartis Institutes for Pfizer, UK Biomedical Research, Novartis, Switzerland The session will review the fundamental tenets of the biosimilar concept The poor prediction of toxicity during early drug development is a major as pioneered by the European regulators and why upholding these is of challenge to bringing more effective medicines to patients. Key opportunities central importance in view of the fact that these concepts are sometimes for enhancing safety sciences include improved characterisation of molecular, misunderstood by stakeholders. We will review the challenges faced by biochemical and cellular pathways of toxicity, together with the development companies in applying these concepts in a global setting and will conclude of predictive tools, models and translational safety biomarkers that allow with a discussion on stakeholder education followed by a panel discussion. discovery researchers and clinicians to anticipate and mitigate safety issues. A safe harbour approach for amassing preclinical/clinical safety data and exploring chemotype-toxicity relationships is essential for an improved Session 1506 | Thursday, 26 March, 11:00-12:30 | 5AB-O1 information flow between bedside and bench. HOW TO REALISE BIOSIMILARS’ FULL POTENTIAL Session Chair: Sundar Ramanan, Strategic Planning & Operations Director, R&D, Amgen, USA Session 1407 | Thursday, 27 March, 14:00-15:30 | NO-O1
NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR The increasing uptake of existing biosimilars has generated considerable MONOCLONAL ANTIBODIES interest and debate about the future potential of the biosimilars space but Session Chair: despite the widespread optimism, a number of key challenges relating to the Guenter Waxenecker, Expert Biologics, Austrian Medicines and Medical known active substance remain – pharmacovigilance, naming and traceability Devices Agency (AGES), Austria – which if not adequately addressed, can limit the potential of biosimilars before it is fully realised. This session will review these three independent This session will provide a reflection on the need for innovative methods for but interlinked challenges, providing case studies and examples to illustrate non-clinical assessment of biosimilar monoclonal antibodies from a regulators key points and reflect on what needs to be done to ensure the conversation and industry perspective and finally will give a view on globalised development remains focused on patient safety first. strategies.
Session 1407 | Thursday, 27 March, 14:00-15:30 | NO-O1
NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR MONOCLONAL ANTIBODIES Session Chair: Guenter Waxenecker, Expert Biologics, Austrian Medicines and Medical Devices Agency (AGES), Austria
This session will provide a reflection on the need for innovative methods for non-clinical assessment of biosimilar monoclonal antibodies from a regulators and industry perspective and finally will give a view on globalised development strategies. SPEAKER INDEX 45
Last Name First Name Session Page Number
Acha Virginia S0105 23 Adams Scott S0806 32 Aggerholm John S0703 32 Alp Nicholas S0608 31 Amini Tina Tutorial 11 & S1108 36 & 18 Ancans Janis S1406 40 Anisimov Vladimir S1404 39 Antonijevic Zoran S0501 29 Arlett Peter S0204 & S0807 25 & 32 Arnoldi Pedersen Mikkel S0808 33 Athey Sarah S0606 31 Atzor Sabine S0104 22 Ayres John S0302 26 Bachmann Peter S1604 42 Baert Lieven S1405 39 Baker Mary S0207 14 & 25 Banerjee Swapu S0302 26 Barker Richard S1006 35 Barnes Yvonne S0603 30 Barron Niall S0607 31 Beaujeux Kate Tutorial 9, S0402 18 & 28 Bedlington Nicola Plenary, S1507 8 & 41 Behring Antje S0202 24 Bergstroem Richard S0102; S0208; S1301; S1305; 1307 22;25;37;38 & 41 Berntgen Michael S1705 42 Bidló Judit S0202 24 Binneman Brendon S0603 30 Blanchard Adrienne S1304 38 Bleich Norbert S1404 39 Bode Gerd Tutorial 5 17 Boehm Jérôme S0205 25 Bogaert Peter S1302 37 & 38 Bolanos Elena S0104 23 Bountra Chas S1408 40 Bourgeois Frederic S1003 34 Bouvier Anne S0304 26 Bowen Linda S1602 & S1604 41 & 42 Bozic Carmen S0305 26 Brandewiede Bernard S0703 32 Brasseur Daniel Tutorial 8 18 Bravo Eduardo ATMP Briefing 9 Bregnhoj Lisbeth S1707 & S1708 43 Briola Andre S0904 33 Brock Ina S1307 38 Brosch Sabine Tutorial 2 16 Bucci-Rechtweg Christina S0402 28 Bücheler Markus S1107 36 Burd Jonathan S0701 31 Bucsics Anna Theme 5, Plenary, S0202 4; 8; 24 & 29 Carr Melanie S0901; S1604; S1705 33 & 42 46 SPEAKER INDEX
Last Name First Name Session Page Number
Chamberlain Chris S1403 39 Cheng Wing S0203 24 Chibout Salah-Dine S1402 & S1408, Theme 14 4; 39 & 40 Churchill Judy Student Tutorial 20 Clamou Isabelle S0102 22 Cominetti Antonella S0401 28 Cook Graham S1205, Theme 12 4 & 36 Cranz Hubertus S1508 41 Creba Judith Theme 4 4 & 28 Cullen Lawrence S0401 28 Danan Gaby Tutorial 2 16 Daniels Moira S1006 35 Danielsson Gunnar S1004 34 de Bernardi Barbara S0307 27 De Jong Jean Philippe S1603 42 de Roeck Karolien S0603 30 de Zegher Isabelle S0702 31 Demangue Sabine S1304 38 Donald Andrew S0202 & S0203 24 Dörr Petra S1005 35 Duarte João S1601 20 & 41 Edwards Brian S0607 & S1008 31 & 35 Edwards Vicki S0101/0301 22 & 26 Eichler Hans-Georg Theme 2; Plenary, S0201; S0205; S0608 4; 8; 24; 25; 31 Engelbergs Jörg S0502 29 Fischer Gerd S1003 & S1208 34 & 37 Fleishman Aaron S0902& S0904 33 Forda Susan S0102 22 Foreman Christopher Theme 13, S1301 4 & 37 France Georges S1208 37 Freedman Scott S0702 32 Frenoy Edith Tutorial 10 18 Freunscht Regina S0604 & S1708 30 & 43 Frijlink Henderick S1405 39 Fritsch Cornelius S1407 40 Fürst-Ladani Shayesteh Theme 11, S1106 4 & 36 Gadberry Aaron S1404 39 Garner Sarah S1006 35 & 39 Geissler Jan Theme 9, S0901 4; 14 & 33 Gibou Magali Tutorial 11 18 Gluud Christian S1304 38 Godfrey Josie S0207 25 Godman Brian S0503 & S0504 29 Goese Markus S1206 37 Gokhale Surendra S0104 22 Goldman Michel S1402 39 Gorman Sharon Tutorial 9 18 Greco Marco S0808 & S1306 33 & 38 Grignolo Alberto S1005 35 Grueger Jens S0203 & S0204 24 SPEAKER INDEX 47
Last Name First Name Session Page Number
Grund Andreas S0604 30 Habl Claudia S0503 29 Haerry David S1003 34 Hallersten Anna S1603 42 Hansson Erik S1106 36 Hartford Craig S0307 27 Hartmann Markus S1008 35 Harvey Allchurch Martin S0305 26 Haspel Joel S0807 32 Heaton Stephen S0308 27 Heddell Gerald S0106 & S1208 23 & 37 Heering Clara Theme 6, S0601 & S0606 4 & 30 Hellbert Karina S1307 38 Henderson Deborah S1602 41 Henzl Martin S1002 34 Heynisch Thomas S0208 & S1506 25 & 40 Hoekstra-van den Bosch Sabina Tutorial 07 17 Hoenel Alexander S1708 43 Hofbauer Karl-Heinz S1900 9 Holthuizen Jessica S0601 30 Høngaard Andersen Peter S1407 & S1408, Theme 14 4; 39 & 40 Hoos Anton S0201 24 Hubbard Tim S1403 39 Hubby Sherri S0605 30 Huber Jan Oliver S1900 9 Hudson Ian S0102 & S0103 9 & 22 Hughes-Wilson Wills S0208, Theme 2 4; 24 & 25 Humphreys Anthony Tutorial 13 & S1705 19 & 42 Hurts Hugo S0208 25 Hynes Carolyn S1601 41 IJzerman Maarten S0207 25 Jacobs Kirsten S1003 34 James Michael S1206 37 James Chris S0201 14 & 24 Janse-de Hoog Truus S1604 42 Javroongrit Yuppadee S1007 35 Jeary Theresa S1106 36 Jefferys David S1704 42 Joos Angelika Programme Co-Chair 3 & 12 Joos Thomas S1402 39 Jusevicius Vytis S1108 36 Kanavos Panos S0207 25 Kaur Primal Tutorial 6 17 & 44 Kent Alistair ATMP Briefing 9 & 43 Kermani Faraz S0305 26 Khatuntsev Alex Young Professional Tutorial 20 Kickbusch Ilona Plenary 8 Kievits Tim Theme 5 4 & 29 Kiser John S0107 23 Kitcatt Victoria S1302 38 48 SPEAKER INDEX
Last Name First Name Session Page Number
Klaushofer Klaus S0208 25 Klech Heinrich S1900 9 Koblar Vesna Theme 15, S1508 4 ; 40 & 41 Köhne Marianne Theme 16, S1602 4 & 41 Kondo Tatsuya S1706 9 & 43 König Steffen S0703 32 Krafft Hartmut S0104 22 Kristensen Finn Borlum S0204 25 Kübler Jürgen Tutorial 4 17 Kutac Niki S0702 31 Lang Thomas S1301 37 Lange Barbara S1505 40 Langel Kai S0904 33 Lanssiers Patricia S1305 38 Laslop Andrea S0403 28 Lassoff Peter S0107 23 Lavery Clare S1603 42 Le Cam Yann S0204 14 & 25 Lindström-Gommers Lenita S1304 38 Lisman John Tutorial 1 16 Llinares Garcia Jordi S0402 & S0403 28 & 35 Lofstedt Ragnar S0305 26 Longson Carole S0201 24 Lumpkin Murray S1006 34 & 35 Macolic Sarinic Viola S0101 & S103 9; 22 & 34 Mader Robert S0502 29 Male Christoph S1900 9 Mancini Elena S0805 32 Marechal-Jamil Julie S1003 34 Marques Alexandra Student Tutorial 20 Mason Shuna S1107 36 Mathur Ambrish S1002 34 Matsouka Yullie S0503 29 Matsuda Yoshihiro S1205 36 Mavris Maria S0901 2; 14 & 33 Mayer-Nicolai Christine S1603 42 McAuslane Neil S1006 35 McDonald Judith S0105 44 Melgara Marcello S0806 32 Metzger Rainer S0502 29 Michael Estelle Theme 10 4 & 34 Michaux Geneviève Theme 13, Tutorial 8, S0401 4; 18; 28 & 37 Moggs Jonathan S1406 41 & 44 Mollet Annette Young Professional Tutorial 20 Molnar Judit Maria S0504 29 Montagne Sarah S1306 38 & 42 Montgomery Frank S1205 36 Müller Markus S1900 9 Nakashima Nobumasa S1007 & S1706 9 ; 35 & 43 Naraynassamy Carl Theme 6, S0603 4; 12 & 30 SPEAKER INDEX 49
Last Name First Name Session Page Number
Natz Alexander S0106 23 Nehrdich Detlef S0703 2 & 31 Nguyen Gerard S0902 14 & 33 Nichols Rob S0701 31 Norga Koen S0402 28 O'Donnell Peter Plenary 8 Olejniczak Klaus Tutorial 5 10 ; 12 ; 17 & 44 Page Katy S0107 23 Park Kevin S1406 40 Parkinson Kay S0901 14 & 33 Parthasarathy Murali S0808 33 Peetso Terje Theme 8, S0805 & S806 4 & 32 Perez-Gutthann Susana S0306 27 Pleticha Rob S0904 14 & 33 Pumplün Sonja Young Professional Tutorial 20 Qiu Jinhai S1007 35 Rägo Lembit Theme 10, S1001 & S1006 4; 34 & 35 Raine June S0101/0301 & S0103 & S0307 & S1306 9; 22; 26; 27 & 38 Ramanan Sundar S1506 40; 41 & 44 Rasi Guido S0103 S1301 9; 22 & 37 Raudsepp Kristin Theme 15, S1507 4; 40 & 41 Raynor Theo S0101/0301 22 & 26 Regenthal Samantha S1305 38 Regnström Jan S0203 & S0501 24 & 29 Reischl Ilona S1108 2 & 36 Rembratt Åsa S1602 41 Rengarajan Badri S0605 12 & 30 Retkowska-Mika Lidia S1505 40 Richardson Peter S1205 & S1206 36 & 41 Robinson Jamie S0306 27 Rodriguez Ana S0601; S0606; S1708 & S1004 30; 31; 34 & 43 Roediger Alexander S0504 2 & 29 Rohde Holger Maria S0901 33 Rosenblatt Mike Plenary 6 Rothkegel Christiane S1704 42 Rys Andrzej Plenary, S0103, S0201, 8; 9; 22 & 24 Sabratnam Sharmila S0304 26 Salmikangas Paula ATMP Briefing 9 & 43 Salmonson Tomas S0103; S0201; S0306 & S1705, Theme 3 4; 9; 26; 27 & 42 Sato Junko S1001 34 Scheeren Joseph S1005 35 Schiestl Martin S1506 41 Schoonderbeek Carla S1505 40 Schuring Henk S1505 40 Schwarz Gabriele S0606; S1707 & S1708 31 & 43 Schwerdtfeger Walter S0103 & S1508 9; 22 & 41 Schyns-Liharska Tsveta S1508 14 & 41 Shabo Amnon S0806 32 Shakir Saad S0308 27 Silva Lima Beatriz S1406 40 50 SPEAKER INDEX
Last Name First Name Session Page Number
Simán Martin S1404 39 Simmen Kenny S1405 39 Simmons Valerie Theme 3; S0307 4; 26 & 27 Sims Jennifer S1407 40 Siviero Paolo S0205 25 Slijkerman Diederick S1302 37 Spatz Martin S1307 38 Spontoni Cristiana S1303 38 Spooner Almath S0307 27 Stephenson Diane S1402 & s1403 39 Stepniewska Beata S1507 41 Stergiopoulos Stella S0606; S0607 & S0904 31 & 33 Stevens Howard S1405 39 Stingelin Nicola S1008 35 Stöckert Isabelle S0101/0301 & S0302 22 & 26 Stöger Alois NO 8 Stokman Peter Theme 7, S0606 & S0701 4; 30 & 31 Strandberg Ola S0807 32 Straus Sabine S0101/0301 & S0307 & S0308 22; 26 & 27 Superti-Furga Giulio S0501 29 Sykes Nick Theme 1, S1008 4;22 & 35 Ter Heerdt Joyce S1306 38 Thalheim Christoph S0208 14 & 25 Timmers Paul S0805 32 Toivonen Markku S0403 28 Ui Hideaki S1402 39 Uterkofler Bernd S1307 38 van Bruggen Hans Theme 8, S0807 & S808 4; 32 & 33 Van de Voorde Kristel S1004 & S1708 34 & 43 Van der Geyten Serge S0704 32 van der Graaff Martin S0503 29 van der Spek Rob S1601 41 Van Dongen Paul Tutorial 1 16 Van Keymeulen Eveline S1303 38 Van Lessen Kloeke Koosje S1303 38 Van Manen Robbert S0605 30 Van Mol Rik S0701 31 Vanhaverbeke Wim S1408 40 Vera Ernesto S1004 34 Verhelst Luc S0107 23 Verplancke Philippe S0704 32 Vintezou Pascale S1005 35 Vogler Sabine S0503 29 Volck Birgitte S0205 25 Vollebregt Erik Tutorial 7, S0805 17 & 32 Vollmar Joachim Tutorial 4, S0608 17 & 31 Von Fritschen Maren S0106 23 von Raison Florian S0403 28 Wald Frans S0703 32 Walsh Colleen S1002 34 SPEAKER INDEX 51
Last Name First Name Session Page Number
Warner Kay S0902 33 Watson John S0401 28 Waxenecker Guenter S1407 40 & 44 Weese Carmen S0704 32 Weise Martina S0105 23 Welin Mats S1206 37 Widler Beat S0604; S1707 & S1708 30 & 43 Wiesinger Petra S0106 23 Wild Claudia S0504 29 Wilken Matthias ATMP Briefing 9 & 43 Windeler Jürgen S0201 24 Windisch Jörg S0105 & S1900 9 & 23 Wirthumer-Hoche Christa Theme 1, Programme Co-Chair, S0106 3; 4; 9 & 22 Wise Lesley S0304 26 Wolf Birgit S1604 42 Wong-Rieger Durhane S0504 14 & 29 Yamamoto Hiroshi S1007 & 1706 35; 43 & 9 Yamori Takao S1706 9 & 43 Yeung Vincent S1707 & S1708 43 Yoo Moo-Young S1007 35 Zühlsdorf Michael S0501 29 Zurlo Maria-Grazia S0101/0301 22
All EuroMeeting Presentations Be a speaker at the EuroMeeting 2015 Available Online Are you interested in speaking at the 27th Annual EuroMeeting presentations are available to all full- EuroMeeting in Paris, France from 13-15 April 2015? conference attendees. Our presentation hosting site is continually updated with available presentations. Please see the EuroMeeting 2015 Paris Call for abstracts in your conference bag or ask for more information at the DIA Booth in the Exhibition Hall. Easy steps to access presenter slides:
1. Access hosting site via the DIA website: www.diahome.org 2. Select presentation of your choice via the search box 3. Open PDF for viewing or save on your device to annotate 2014-2015
DIA EUROPE MIDDLE EAST & AFRICA Training Courses
Chemistry, Manufacturing and Controls (CMC) / Quality Safety and Pharmacovigilance
Quality by Design - New concepts for chemical and biotech product development Signal Management in Pharmacovigilance and optimisation 21-22 May 2014 | Prague, Czech Republic | ID 14534 22-24 September 2014 | Vienna, Austria I ID 14543 November 2014 | Paris, France I ID 14549
Global CTD Dossier – Regulatory aspects and focus on quality documentation Pre-Marketing Clinical Safety including concepts of Quality by Design 16-17 June 2014 | Amsterdam, the Netherlands | ID 14539 November 2014 | Location to be confirmed I ID 14553 Post-Authorisation Safety Studies (PASS) NEW OFFERING! 18-19 June 2014 | Amsterdam, the Netherlands | ID 14535 Clinical Research Medical Approach in Diagnosis and Management of ADRs Clinical Project Management – Part I 22-23 September 2014 | Paris, France I ID 14540 22-24 September 2014 | Paris, France I ID 14542 Diagnosis and Management of Drug-Induced Liver Injury (DILI) Practical GCP Compliance Auditing of Trials and Systems 23-24 September 2014 | Paris, France I ID 14544 22-24 October 2014 | London, United Kingdom | ID 14531 ICH Endorsed Pharmacovigilance Clinical Statistics for Non-Statisticians 21 October 2014 | Dakar, Senegal I ID 14559 23-24 October 2014 | London, United Kingdom | ID 14532 November 2014 | Algiers, Algeria I ID 14560
Essentials of Clinical Study Management How to Prepare for Pharmacovigilance Audits and Inspections 5-7 November 2014 | London, United Kingdom I ID 14557 November 2014 | Paris, France I ID 14550
Clinical Project Management – Part II 10-12 November 2014 | Barcelona, Spain I ID 14555 European Medicines Agency Information Days and Courses Non-Clinical Safety Sciences PSUR Information Day 29 April 2014 | London, United Kingdom I ID 14504 Non-Clinical Safety Sciences and Their Regulatory Aspects Date and location to be confirmed ICSR Information Day 13 May 2014 | London, United Kingdom | ID 14502 Regulatory Affairs Excellence in Pharmacovigilance: Clinical trials and post-marketing 13-17 October 2014 | London, United Kingdom I ID 14548 Paediatric Investigation Plans (PIP) 13-14 May 2014 | London, United Kingdom I ID 14552 MedDRA Information Day November 2014 | London, United Kingdom Essentials of European Regulatory Affairs NEW OFFERING! 23-24 June 2014 | Amsterdam, the Netherlands | ID 14541 EnCePP Information Day 3-4 November 2014 | Paris, France I ID 14556 Autumn 2014 | London, United Kingdom | ID 14503
Good Management of Medical Devices 23-25 June 2014 | Amsterdam, the Netherlands | ID 14536 EudraVigilance courses: • EudraVigilance – Electronic reporting of ICSRs in the EEA EU Regulation of In Vitro Diagnostics (IVDs) NEW OFFERING! • eXtended EudraVigilance Medicinal Product Dictionary 26 June 2014 | Amsterdam, the Netherlands | ID 14538 • Introduction to Pharmacovigilance and Rules for Expedited Reporting of Health Technology Assessment (HTA) Individual Case Safety Reports (ICSRs) in Europe 13-14 October 2014 | Paris, France I ID 14551 Courses throughout the year | European Medicines Agency, London, United Kingdom How to Prepare for your Meeting with Health Authorities and selected European cities. 14-15 October 2014 | Paris, France I ID 14546 For information on EudraVigilance courses, please visit www.diahome.org > Meetings Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in & Training > About Meetings & Training > In-Person Instruction > EudraVigilance > Europe EudraVigilance Courses 22-24 October 2014 | London, United Kingdom I ID 14545 For more information and a complete listing of all DIA offerings, please visit: US Regulatory Affairs: A comprehensive review of regulatory procedures for INDs www.diahome.org click > on Meetings & Training and NDAs in the US contact DIA in Europe on +41 61 225 51 51 or email: [email protected] 5-7 November 2014 | London, United Kingdom I ID 14554
Approval of generic medicines in the EU. Focus on CMC requirements and bioequivalence Date and location to be confirmed
For more information and a complete listing of all DIA conferences and training courses, please visit: www.diahome.org > click on Meetings & Training Call DIA Europe on +41 61 225 51 51 or email: [email protected] euromeeting 2014 glossary 53
EUROMEETING 2014 GLOSSARY of TERMS
ADR ...... Adverse Drug Reaction AR...... Assessment Report ASMF ...... Active Substance Master File ATMP...... Advanced Therapy Medicinal Product BSWP...... Biostatistics Working Party CAT ...... Committee for Advanced Therapies DIA EUROPE MIDDLE EAST & AFRICA Training Courses CDASH...... Clinical Data Acquisition Standards Harmonisation CDISC ...... Clinical Data Interchange Standards Consortium CDM...... Clinical Data Management CHMP...... Committee for Medicinal Products for Human Use CMC...... Chemistry, Manufacturing & Controls COMP...... Committee for Orphan Medicinal Products CP...... Centralised Procedure CRF ...... Case Report Form CRO...... Clinical Research Organisation DCP...... Decentralised Procedure eCTD...... Electronic Common Technical Document EDC...... Electronic Data Capture EVMPD ...... EudraVigilance Medical Product Dictionary EHR ...... Electronic Health Record ENCePP...... European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ePRO...... Electronic Patient Reported Outcomes EUnetHTA ...... European network for Health Technology Assessment GCP...... Good Clinical Practice GHTF...... Global Harmonisation Task Force GLP...... Good Laboratory Practice GMP...... Good Manufacturing Practice GXP...... Good Practice HMA...... Heads of Medicines Agencies HMPC...... Committee on Herbal Medicinal Products HTA...... Health Technology Assessment ICH ...... International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICSR ...... Individual Case Safety Report IDMP ...... Identification of Medicinal Products IMI...... Innovative Medicines Initiative ISO ...... International Organization for Standardization ISO IDMP...... International Organization for Standardization Identification of Medicinal Products IVDD...... In-Vitro Diagnostics Directive MA ...... Marketing Authorisation MedDRA...... Medical Dictionary for Regulatory Activities MRP...... Mutual Recognition Procedure NBCD...... Non-Biological Complex Drugs PAR...... Public Assessment Report PASS...... Post-Authorisation Safety Study PIP ...... Paediatric Investigation Plan PDCO...... Paediatric Committee PRAC...... Pharmacovigilance Risk Assessment Committee PRO...... Patient Reported Outcomes PSUR...... Periodic Safety Update Report QbD ...... Quality by Design RPS...... Regulated Product Submission QPPV...... Qualified Person for Pharmacovigilance SAWP...... Scientific Advice Working Party SDTM ...... Study Data Tabulation Model SME...... Small and Medium-sized Enterprises SMQ ...... Standardised MedDRA Query RPS...... Regulated Product Submission XEVPRM...... eXtended EudraVigilance Product Report Message 54 NETWORKING
Networking Events All Included in your Registration FEE!
Networking is an integral part of the EuroMeeting. Past attendees tell us that the networking opportunities presented by the EuroMeeting are one of the key reasons for attending. Each year, the EuroMeeting offers numerous opportunities to catch up with existing contacts and to make new ones in a relaxing setting. All networking events at the EuroMeeting are included in the registration fee.
EuroMeeting Grand Opening Reception Tuesday, 25 March 2014 | 17:30-19:00 in the Exhibition Hall Join us at the Grand Opening Networking Reception for an excellent opportunity to renew your existing contacts and to make new ones. It is exclusive to registered EuroMeeting attendees and will take place in the Exhibition Hall.
The DIA Award Ceremony will take place at the DIA Booth at the beginning of the Opening Reception.
Patient Fellowship Networking Lunch Tuesday, 25 March 2014 | 12:45-13:45 Patient Representatives and Patient Speakers only
Student and Young Professional Networking Reception Monday, 24 March 2014 | 17:30 - 18:30 The Student and Young Professionals Reception is an opportunity to get to know each other better before the conference begins.
Student Poster Award Ceremony at the DIA Booth on the Exhibition Floor Wednesday, 26 March 2014 | 17:45
DIA Communities – Meet and Eat Wednesday, 26 March 2014 | 12:30-13:15 An opportunity for all Community members – and those interested in joining one – to get together for networking at lunchtime.
Speed Networking Session Tuesday, 25 March 13:00 – 13:30 | Wednesday, 26 March 13:30 – 14:00 The EuroMeeting is used as a networking opportunity by all participants. However, it is not easy to walk right up to someone, introduce yourself and have a conversation. The EuroMeeting Speed Networking session aims to make this process a lot easier.
Speed networking, which is actually based on the original concept of speed dating, brings together individuals who are attending a conference. It will help you to make new contacts and intensify your networking experiences. The goal is to ensure that each participant will make at least six new professional contacts during the speed networking sessions.
Wednesday Reception Wednesday, 26 March 2014 | 17:30-18:30 Wednesday’s networking reception takes place in the Exhibition Hall. Drinks and snacks are included. It is open to all registered attendees.
Network on the Exhibition Floor All refreshments will be served in the Exhibition Hall, making it the ideal place to meet the people you want to meet. There will be an internet café and attendee lounge as well as a seating area. exhibition EXHIBITION HALL FLOOR PLAN 55
Member Lounge PLAN E X HIBI T ION HALL FLOOR 56 EXHIBITORS ExhibitORS Exhibiting Companies as of 7 March 2014
Company Country Booth N° Entimo AG Germany X.215
Accenture United Kingdom X.618 EPID Research Finland Y.726
Acurian United States Y.416 ERT Inc. United States X.418, X.319
Advanced Clinical Recruitment Ltd United Kingdom S.16 EUDRAC Ltd United Kingdom X.613
AICROS Ltd Germany Y.711 European Medicines Agency United Kingdom X.605
Applied Clinical Trials United States X.206 European Pharminvent Services Ltd Czech Republic X.400
Aptiv Solutions United States X.313 Eurotrials Portugal X.710
“ARAC” GMBH / S2 GmbH Austria X.219 EXTEDO GmbH Germany X.401
ARCHIE SAMUEL s.r.o. / Regulatory House Czech Republic X.804 FLEX DATABASES Russia X.601
ArisGlobal United Kingdom X.210, X.212 Foresight Group International United States X.414 arivis AG Germany X.426 FORMPIPE software ab Sweden Y.507
Arriello Group Ireland X.600 Global Clinical Trials LLC Russia Y.720
ASPHALION Spain X.422 goBalto United States X.706
AXPHARMA SAS France X.718 Hays Life Sciences United Kingdom X.205
Barrington James United Kingdom X.700 Hydrogen United Kingdom S.4
BASECON A/S Denmark X.419 i4i Inc. Canada X.227
Berlinger & Co. AG Switzerland S.2 ICON United Kingdom Y.719
Bio-Images Group Ltd United Kingdom Y.406 IMI Education & Training Austria S.8
BIOMAPAS Lithuania Y.617 IMS Health United States X.622
BioPharm Insight United States T.15 INFOTEHNA Group LLC Slovenia X.726
CamNtech Ltd United Kingdom Y.713 Innovative Medicines Initiative (IMI) Belgium X.520
Cardiocore United States X.312 Insight Medical Writing United Kingdom X.522
Carrot Pharma United Kingdom Y.715 Integrated Clinical Systems, Inc. United States X.327
Clinical Contract Research Association (CCRA) United Kingdom Y.513 IST GmbH Germany X.707
CMIC Holdings Co., Ltd Japan X.505 JULIUS CLINICAL The Netherlands Y.611
CPRD, The Clinical Practice Research Datalink United Kingdom Y.306 KCR S.A. Poland X.812
CTC Clinical Trial Consulting Switzerland X.501 Keyrus Biopharma SA Belgium X.315
DATATRAK United States X.507 Kinapse United Kingdom X.223
DDi United Kingdom T.3 LASER ANALYTICA United Kingdom X.727
DIA Switzerland X.504 Lindeq Norway X.518
DIA Patient Fellowship Switzerland X.805, X.807 LORENZ Life Sciences Group Germany X.714
DIA Student Corner Switzerland Y.708, Y.710 MakroCare United Kingdom T.1
Dianthus Medical Ltd United Kingdom Y.511 MasterControl Global Ltd United Kingdom Y.217
Dora Wirth (Languages) Ltd United Kingdom Y.610 Max Application srl Italy X.810
Dove Medical Press United Kingdom Y.712 MedDRA MSSO United States X.300
Drug Safety Research Unit United Kingdom X.420 MEDICADEMY Denmark X.607 emedcareers.com United Kingdom Y.718 Medicines Evaluation Unit Ltd United Kingdom Y.512
Ennov France Y.216 MEDIS Research Group / Germany X.500 EXHIBITORS 57 ExhibitORS Exhibiting Companies as of 7 March 2014
Creative Clinical Research GmbH RxLogix Corporation United States X.423
MonitorForHire.com United States X.213 Samarind Limited United Kingdom X.720
Moravia IT as Czech Republic X.318 SanaClis s.r.o. Slovakia X.806
MyMedsandMe United Kingdom X.713 Schlafender Hase GmbH Germany X.207
Nanokinetik United Kingdom S.6 SGS Life Sciences Services Switzerland Y.117
NDA Group Sweden X.701, X.800 Sharp Clinical Services United Kingdom Y.404
NextDocs United States X.301 Tarius Denmark X.410
NNIT A/S Denmark Y.111, Y113, Temple University / United States T.7 Y.210, Y.212 National University of Singapore
NonStop Recruitment Ltd United Kingdom Y.417 The Conference Forum United States Y.717
Novella Clinical Resourcing United Kingdom Y.604 The Regulatory Affairs Company United Kingdom Y.413
Online Business Applications United States X.211 the Uppsala Monitoring Centre Sweden X.712
Oracle United Kingdom X.621, X.623 The Weinberg Group United States X.200
Packaging Coordinators Inc. United Kingdom Y.606 Thomson Reuters United States X.619
PaediaCRO GmbH Germany X.722 TOPRA United Kingdom T.21
ParagonRx United States T.17 TransPerfect United Kingdom X.304, X.306
PAREXEL United States X.321 Trilogy Writing and Consulting GmbH Germany X.218
Paspartu Translation Services Greece Y.316 Truven Health Analytics United Kingdom X.310
Pharma Consulting Group AB (Viedoc) Sweden X.611 United BioSource Corporation United States Y.619
Pharmaceuticals and Medical Devices Agency Japan X.704 Universal Medica France X.323
PharmAdvice Aps Denmark Y.213 Valos srl Italy X.111
PharmaForms / Amedon Germany X.705 Veeva Systems United Kingdom X.814, X.715
Pharmalink Consulting Ltd United Kingdom X.320, X.322 Vienna Convention Bureau Austria Y.516
Pharmathen S.A. Greece X.214 XClinical GmbH Germany X.314
PharmaTimes United Kingdom T.5 Xendo the Netherlands X.813
PHARMIWEB.COM United Kingdom X.115
PHT Corporation United States X.311
Pope Woodhead and Associates Ltd United Kingdom Y.317
PrimeVigiliance United Kingdom Y.411, Y.510
ProClinical Ltd United Kingdom Y.612
ProductLife Group France X.519, X.521
Quality and Compliance Consulting, Inc. United States X.711
QUMAS Ireland X.627
Real Regulatory Limited Ireland X.412
Real Staffing Zurich United Kingdom Y.307
Regulatory Pharma Net s.r.l. Italy X.615
RJR Consulting Inc. and ADS Insight United States X.204
RWS Group United Kingdom Y.312 58 EXHIBITOR SUMMARIES
Accenture Life Sciences Booth X.618 ArisGlobal Booth X.210,X.212 Contact : Nicola Beall I Website: www.accenture.com Contact: Kathy Capper I Website: www.arisglobal.com Accenture is a global management consulting, technology services and Email: [email protected] outsourcing company, with approximately 281,000 people serving clients in ArisGlobal is the leading provider of integrated solutions for pharmacovigilance more than 120 countries. Combining unparalleled experience, comprehensive & safety, regulatory affairs, clinical research, and quality & compliance for capabilities across all industries and business functions, and extensive research medical inquiries. Life science companies using our solutions can better build on the world’s most successful companies, Accenture collaborates with clients to and maintain the trust they need with their customers, medical practitioners and help them become high-performance businesses and governments. global regulatory bodies.
Acurian Booth Y.416 arivis AG Booth X.426 Email: [email protected] I Website: www.acurian.com Contact: Andreas Suchanek I Website: www.arivis.com Acurian is a full-service provider of clinical trial patient enrollment & retention Email: [email protected] solutions. Acurian increases enrollment performance of sites worldwide by arivis AG develops and markets solutions (software and services) for the Life identifying, contacting, prescreening & referring people who live locally, but are Sciences industry (pharmaceutical, biotech, medical devices, crop science). Thus unknown to sites. As a result, sponsors complete enrollment without adding sites, customers are supported in achieving the perpetually increasing requirements time or CRO change orders. in the highly regulated environment in compliance in research, production, submission and quality assurance of medical products. Advanced Clinical Recruitment Ltd Booth S.16 Contact: John Swift I Website: www.acr-uk.com Arriello Group BoothX.600 Email: [email protected] Contact: Alan White I Website: www.arriello.com Advanced Clinical Recruitment is a specialist recruitment service, whose only Email: [email protected] focus is to supply candidates to the Pharmaceutical industry. We have ongoing We are a Life Science industry service provider that works as a truly professional positions available with the world’s largest Biotech/Pharmas & CROs in Western/ network. We are a team with a project-oriented management focus from Eastern Europe & the world. Our service is of the highest standard & with over preparation to delivery, using a proactive approach to ensure that all your needs 10 years experience in the industry we offer a considerate & comprehensive are fully covered. We cover Regulatory Affairs, Pharmacovigilance, Medical recruitment process. Writing and Translations.
AICROS Ltd. Booth Y.711 ASPHALION Booth X.422 Contact: Dr. Andreas Grund I Website: www.aicros.com Contact: Lidia Cánovas I Website: www.asphalion.com Email: [email protected] Email: [email protected] The Association of International CROs (AICROS) is an official network of small to Founded in 2000 and with over 35 professional consultants, ASPHALION midsize CROs which provide clinical research services for the pharmaceutical and has working groups for International Registration Procedures, Clinical and medical device industry for many years. We have an ability to conduct international Medical Writing, Electronic Submission of Regulatory Data, CMC/Quality and trials like a global CRO but give sponsors a whole range of advantages of smaller Pharmacovigilance. CROs. AICROS is a reliable partner for all companies which needs to run global clinical trials but do not like to work with large CROs. AXPHARMA SAS Booth X.718 Email: [email protected] I Website: www.axpharma.com Applied Clinical Trials Booth X.206 AXPHARMA: Leading CSO dedicated to outsourcing of Pharmacovigilance and Contact: Charu Jhalani and Anne Young Medical Information - 24/7 Medical call center - services. Offices in Paris, Brussels, Website: www.appliedclinicaltrialsonline.com Lausanne with teams of MD and PHD highly experimented and adaptable. Email: [email protected] Clients are big/medium international Pharmas. Expertise covers all types of Applied Clinical Trials is the authoritative,peer-reviewed resource and thought medicines,biosimilars and medical devices. leader for the global community that designs, initiates, manages, conducts and monitors clinical trials. AppliedClinical Trials is the only brand dedicated Barrington James BoothX.700 exclusively to clinical trials and reaches over 140,000 industry professionals Contact: Loti Jackson I Website: www.barringtonjames.com globally. We provide this information with a multiplatform approach of print, Email: [email protected] online, webinars, whitepapers, video and newsletters. Barrington James are a global specialist recruitment consultancy working across the Healthcare sector. Our structure, with separate divisions and dedicated Aptiv Solutions Booth X.313 consultants for the markets we serve ensures a thorough, professional and Contact: Lisa King I Website: www.aptivsolutions.com intelligent approach in both permanent and interim solutions. Our tailored Email: [email protected] methodologies include contingency database search and executive search. Aptiv Solutions is a global biopharmaceutical and medical device services company focused on recognizing, understanding and enabling clients to BaseCon Booth X.419 capitalize on rapid and fundamental changes surrounding the development of Contact: Morten Kjær I Website: www.basecon.com pharmaceutical, biotech and medical device products. The company offers clients Email: [email protected] an extensive portfolio of innovative services supported by over 850 professionals Drug Safety Solutions for the Modern Pharmaceutical Industry. BaseCon provides in North America, Eastern & Western Europe, Israel and Japan. a complete Pharmacovigilance Safety System hosted from our pre-validated GxP hosting center. SafetyBase Interchange is suitable for all drug safety organisations ARAC” GMBH / S2 GmbH Booth X.219 and departments. Come visit us and try our fantastic new mobile app and our Email: [email protected] I Website: www.aracgmbh.com easy to use applications. Services ARAC: Regulatory Affairs & Strategy, Market Access, Pharmacovigilance, Due Diligence, Audits, Pharmaceutical Development, Pre-clinical and Clinical Development, Project Management Services S2: Clinical Trial Applications, Monitoring, NIS, PMOS, PASS, Auditing, GCP Training, Project Management. EXHIBITOR SUMMARIES 59
Berlinger & Co. AG Booth S.2 Clinical Contract Research Association (CCRA) Booth Y.513 Contact: Andreas Giger I Website: www.berlinger.ch Contact: Ms. Susan Dilks I Website: www.ccra.org.uk Email: andreas.giger@berlinger Email: [email protected] Berlinger & Co AG, founded in 1865, is a family run company based in Switzerland. If you are serious about the conduct of clinical trials to the highest standards and As one of the leading manufacturers of temperature monitoring systems, take any part in the industry (CRO or service provider in this sector) come and Berlinger & Co.AG has provided the pharmaceutical and other industries with talk to us about membership! CCRA is the UK trade association which represents reliable and easy to use temperature indicators for over 25 years.It started first this sector and provides enhanced business opportunities, a badge of quality and with chemical-based indicators and moved on to electronic indicators and loggers a voice for the industry. such as Freeze-tag®,Q-tag® and Fridge-tag®. CMIC HOLDINGS Co. Ltd Booth X.505 Bio-Images Group Ltd Booth Y.406 Contact: Aya Sasada Contact: Lee Ann Hodges I Website: www.bio-images.co.uk Email: [email protected] Email: [email protected] Your Strategic Partner to Lead You into the Asian Market CMIC is a one-stop We provide scintigraphic imaging for visualisation of how formulations behave in gateway to the Asian market supporting pharmaceutical, biotechnology and man. Coupled with PK sampling, this technique can help validate product claims, medical device companies. Our quality services include pre-clinical and clinical troubleshoot formulation problems and demonstrate formulation superiority. research management, site management, manufacturing, sales / marketing, and Scintigraphy can be combined with the IntelliCap wireless drug delivery capsule consulting services which will be tailored to fit your for regional absorption studies. CPRD, The Clinical Practice Research Datalink Booth Y.306 BIOMAPAS Booth Y.617 Contact: Maggie Massam I Website: www.cprd.com Contact: Donatas Grina I Website: www.biomapas.eu Email: [email protected] Email: [email protected] CPRD delivers major efficiencies to the clinical trials process via new digital Biomapas is a Clinical Research Organisation (CRO) operating in Central platforms that enable fast access to large national data sets. Services include near and Eastern Europe. Biomapas offers multi-disciplinary solutions for the real time feasibility, protocol optimisation and patient and site recruitment. Visit pharmaceutical industry ranging from Phase I-IV clinical trials management/ us to find out how a National Healthcare System approach can deliver a step monitoring and clinical safety, all the way up to product registration, regulatory change in clinical research. affairs and post-approval pharmacovigilance. CTC Clinical Trial Consulting AG Booth X.501 BioPharm Insight Booth T.15 Contact: Manu Chhokra I Website: www.ctcresourcing.com Contact: Anil Kumar I Website: www.biopharminsight.com Email: [email protected] Email: [email protected] CTC Resourcing solution is a key provider of flexible resourcing solutions to BioPharm Insight combines the most comprehensive real-time database of Pharma/Biotech, Med Devices and CROs. Referred to as the gold standard by our companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial candidates and clients, we have a strong track record of engaging and placing the data with proprietary forward-looking intelligence uncovered by an independent very best talent in Clinical, pre-Clinical, Safety, and Regulatory/Med Affairs roles. team of investigative journalists months or even years before it breaks in mainstream media. DATATRAK Booth X.507 Contact: Lisa Pahl I Website: www.datatrak.com CamNtech Ltd Booth Y.713 Email: [email protected] Contact: Loretta Clark I Website: www.camntech.com DATATRAK is the leader of unified eClinical® technologies and related services Email: [email protected] for the clinical trials industry. Using the DATATRAK ONE™ cloud-based clinical CamNtech provides wearable solutions for objective monitoring of sleep quality, research platform, DATATRAK’s Clinical and Consulting Services group assists energy expenditure, Activity, HRV, EEG, EMG and Patient Reported Outcome. Our clients in conducting global Phase I-IV drug and device studies in multiple products have regulatory approvals for major world markets, backed up by our languages. worldwide network of distributors and from our facility in the UK and offices in the USA. DDi Booth T. 3 DDi (Drug Development informatics) is an e-Clinical and Data Integration Cardiocore Booth X.312 services company and a prominent partner to provide clinical informatics and IT Contact: Scott Satin I Website: www.cardiocore.com solutions to the Life Sciences industry. DDi presenting its ClinMetanoia, mEDC Email: [email protected] and Integrated Biometric Services. As a BioTelemetry company, Cardiocore is part of the world’s largest cardiac analytics infrastructure. We analyze 1 billion heart beats a day. We support DIA Patient Fellowship Booth X.805 10,000 sites and track nearly 20,000 patients monthly. And we employ over 900 DIA actively promotes the involvement of patients representatives in the experienced professionals offering superior global services, expert consulting and EuroMeeting. The Patient Fellowship Booth on the Exhibition Floor acts as a focal advanced cardiac data management. point for Patient Fellows and Patient Speakers to network and meet with industry representatives, regulators and other attendees. Patient posters will be on display Carrot Pharma Recruitment Booth Y.715 adjacent to the patient booth. Contact: Debbie Anderson I Website: www.carrotpharma.co.uk Email: [email protected] DIA Student Corner Booth Y.708,Y.710 Carrot Pharma Recruitment is a specialist recruitment agency working within the DIA actively promotes the involvement of students in the EuroMeeting. The pharma and healthcare industries across the following sectors: clinical research, Student Booth acts as a focal point for Students and Young Professionals to medical affairs, pharmacovigilance, quality assurance, regulatory, compliance, network and meet with industry representatives, regulators and other attendees. sales and marketing, advertising, pr, market research and business intelligence, Student posters will be on display close to the student booth. market access, pricing & reimbursement, heor and medical communications. Dianthus Medical Limited Booth Y.511 Contact: Ruth Allwood I Website: www.dianthus.co.uk Email: [email protected] Dianthus Medical is an innovative company providing medical writing and analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector. 60
Dora Wirth (Languages) Ltd. Booth Y.610 ERT Booth X.418, X.319 Contact: Samuel J. Wirth I Website: www.dwlang.com Contact: Sheryl Walder | Website: www.ert.com Email: [email protected] Email: [email protected] Dora Wirth Languages Ltd. (est. 1962) is your reliable partner offering global ERT is a leading provider of high-quality patient safety and efficacy endpoint life sciences solutions in regulatory affairs and clinical/medical research. DWL data collection solutions for use in clinical drug development. ERT delivers combines specialist translation services for the pharmaceutical industry with in solutions in: Centralized Cardiac Safety, Respiratory Services, Clinical Outcome house medical expertise, a proven track-record of dedication to the field, and a Assessments (COA) –ePRO, eClinRO, eObsRO, Suicidality Risk Monitoring, and strong commitment to quality and service. related consulting.
Dove Medical Press Booth Y.712 EUDRAC Ltd Booth X.613 Contact: Dr Sandra Le I Website: www.dovepress.com Contact: Carole Pugh | Website: www.eudrac.com Email: [email protected] Email: [email protected] Dove Medical Press is an open access Publisher of 130+ peer reviewed biomedical EUDRAC is an EU regulatory affairs consultancy based in UK, Germany and France. and scientific journals, which focus on medicine, drug treatment, clinical risk Our services to pharmaceutical & medical device companies extend through the management, outcomes research and adherence across a breadth of disease development, registration, market launch and life cycle management phases, states and technologies, biology and basic sciences. including e-CTD publishing. Our clients value our high quality work performed according to project timelines. Drug Safety Research Unit BoothX.420 Contact: Becci Petch I Website: www.dsru.org European Medicines Agency Booth X.605 Email: [email protected] Contact: Beatrice Fayl | Website: www.ema.europa.eu The DSRU is an independent academic unit with respected pharmacovigilance Email: [email protected] and pharmacoepidemiology expertise which conducts studies to support risk The European Medicines Agency is the European Union body responsible for management plans in primary and secondary care. Our methods include Specialist coordinating the existing scientific resources put at its disposal by member states Cohort Event Monitoring (SCEM), Modified Prescription-Event Monitoring for the evaluation, supervision, and pharmacovigilance of medicinal products (M-PEM), registries and drug utilisation studies. European Pharminvent Services Ltd. Booth X.400 emedcareers.com Booth Y.718 Contact: Dr Jan Petracek, MD, MSc | Website: www.pharminvent.com Contact: Gareth Robba I Website: www.emedcareers.com Email: [email protected] Email: [email protected] PharmInvent is a unique provider of scientifically integrated pharmacovigilance emedcareers.com is the place to find the latest European jobs in the and regulatory science strategies. The exceptional experience from EMA and Pharmaceutical and Medical Device industries. Simply register for job alerts regulatory agencies, practical industry experience and established EU network of and we’ll send you the latest matching jobs by email every day. Why not also QPPVs make PharmInvent a preferred CSO to clients in small molecules, biologics upload your CV, make it searchable and let employers and recruitment agencies and advanced therapies. approach you with suitable jobs? Eurotrials Booth X.710 ENNOV Booth Y.216 Contact: Maria João Queiroz, MD | Website: www.eurotrials.com Contact: Olivier Paris | Website: www.ennov.com Email: [email protected] Email: [email protected] Eurotrials is a privately owned CRO focused in Europe and Latin America Ennov is a software publisher specializing in Electronic Document Management markets, with strong local expertise. Eurotrials has been validated by international with a single focus: delivering cost effective, best-of-breed, off the shelf, highly R&D companies and has several Master Agreements. With almost 20 years of configurable, user friendly solutions to our clients. Ennov solutions assist experience, our services span from Clinical Research to Epidemiology, Regulatory companies and organizations align their daily activities in conformity with their Affairs, Pharmacovigilance, Health Economics, Data Management and Biostatistics external and internal regulations and legal environment to gain the true value of their business content. EXTEDO GmbH Booth X.401 Contact: Thomas Kessler | Website: www.extedo.com Entimo AG Booth X.215 Email: [email protected] Contact: Jörn Bilow | Website: www.entimo.com EXTEDO is the key software and service solutions provider in the field of Email: [email protected] Regulatory Information Management (RIM). The EXTEDOsuite covers product Entimo provides superior quality IT products, custom solutions and reliable registration planning & tracking (IDMP), submission publishing & lifecycle services streamlining the clinical development process. entimICE® Integrated mgmt. and pharmacovigilance. Today, EXTEDO serves over 700 customers in 60 Clinical Environment provides: countries, including the EMA and more than 25 regulatory authorities worldwide -Data/Metadata repository -Standards management Flex Databases Booth X.601 -Data transformation to SDTM, ADaM and other models Contact: Olga Loginovskaya | Website: www.flexdatabases.com -Statistical computing environment Email: [email protected] -Define.xml generation Flex Databases is a software company that offers web-based modular systems for automation of business processes in clinical trials: CTMS (Project Management, EPID Research Booth Y.726 CRA Site visits, Invoicing, Subject Tracking, Investigators & Sites Management, Contact: Pasi Korhonen | Website: www.epidresearch.com Time Sheets) and Learning Management System (SOP Management, Classroom & Email: [email protected] Self-training, Knowledge Testing). EPID Research provides pharmacoepidemiological research services for pharmaceutical companies, healthcare organizations and authorities. We study Foresight Group International Booth X.414 the use and effects of drugs in large numbers of people by utilizing population- Email: [email protected] | Website: www.foresightgroup.com wide healthcare registers. Our studies provide information on effectiveness, Foresight Group is a global professional services company focused exclusively adverse effects and costs of drug treatment. on drug safety and surveillance and risk management services and solutions. We specialize in PV process design and optimization, drug safety database implementation and hosting, reporting, signal detection, risk management and inspection readiness and response. 61
Formpipe Booth Y.507 INFOTEHNA Group LLC Booth X.726 Contact: Sophia Rosenlöf I Website: www.formpipe.com/lifescience Email: [email protected] I Website: www.infotehna.com Email: [email protected] INFOTEHNA is leading provider of Document Management Software, specialized Formpipe provides electronic quality management systems (EQMS) for companies for Pharma Industry, with more than 20 years of experience. Its solutions have operating within strict GxP regulatory environments such as pharmaceutical, over 5000 users in more than 20 countries. With offices in Germany, USA, India, medical device, biotech and other life science organisations. Platina QMS is a Turkey, Slovenia and Croatia, INFOTEHNA is globally present and valued partner web-based modular system with an easy-to-use user interface that improve your of world’s largest Pharma companies. organisations efficiency on every level. Innovative Medicines Initiative (IMI) Booth X.520 Global Clinical Trials, LLC Booth Y.720 Contact: Alessandra Paccamiccio I Website: www.imi.europa.eu Contact: Anna Kuzmicheva I Website: www.gctrials.com Email: [email protected] Email: [email protected] With a €2bn budget, the Innovative Medicines Initiative (IMI) is the world’s GCT is a regional CRO headquartered in Princeton, NJ, with full-service clinical largest life sciences public-private partnership. Its collaborative projects bring operations in Russia, Ukraine, Bulgaria and Romania. Since 2001, we provide together experts from industry, academia, SMEs, patient groups and regulators individual approach, flexible pricing, fast patients’ recruitment, and high quality – developing tools and technologies that will speed up the development of safer clinical development services. We do all phases and all indications within GCP/ and better drugs for patients. EMA/FDA standards. Insight Medical Writing Booth X.522 goBalto, Inc. Booth X.706 Contact: Tim Griffiths I Website: www.insightmw.com Contact: Michael Thompson I Website: www.gobalto.com Email: [email protected] Email: [email protected] A leading regulatory writing service for over a decade. Our experienced team goBalto is an award-winning group of industry veterans. Our flagship product, provide a full range of high quality documents from preclinical to submissions, Tracker, is a cloud-based clinical research platform. It enables clinical trial sponsors regulatory responses and risk management across multiple therapeutic areas. and research organizations to track critical path milestones, and provides Experts in submissions, our professional documents ensure smooth progress document workflow management in a clear, compliant, user-friendly way. through approval and beyond.
Hydrogen Group Booth S.4 Integrated Clinical Systems, Inc. Booth X.327 Contact: Ray Brooks I Website: www.hydrogengroup.com Contact: Eric S. Herbel I Website: www.i-review.com Email:[email protected] Email: [email protected] Hydrogen is a global specialist recruitment business. Our expert consultants focus Integrated Clinical Systems - developers of Integrated Review™ and JReview® on niche areas including biometrics, clinical research and operations, medical, the fastest and easiest way to review, graph, visualize, report, analyze, do patient production and engineering, quality and regulatory affairs. We work as long term, profiles and patient narratives and Risk Based Monitoring for your clinical data. trusted advisor to our candidates, who often choose to work with us exclusively Works with OC,Clintrial,SAS datasets, Oracle LSH, SAS DD, Medidata Rave, throughout their careers. EntimICE. i4i Inc. Booth X.227 IST GmbH Booth X.707 Contact: Lynn Walks I Website: www.i4i.com Contact: Reinhard van der Does I Website: www.istgmbh.com Email: [email protected] Email: [email protected] The leader in Structured & Collaborative Authoring (Word-based), i4i’s powerful IST is a mid-sized full-service, innovative CRO committed to high professional XML-based products are used by over 70 global pharmaceutical clients to standards, adherence to timelines and budgets. In addition to high-quality manage compliant regulatory content. i4i’s complete lifecycle platform leverages consultancy services, we have run large multinational studies (biggest: 60 xml content to streamline key business processes including; review/approval, countries, 700 sites, 14,000 patients). A wealth of publications and congress translation & parallel submissions. contributions has resulted from our work.
ICON Booth Julius Clinical Booth Y.611 Contact: I Website: Contact: Aernout van Haarst I Website: www.juliusclinical.com Email: Email: [email protected] Julius Clinical is a unique academic research organization(ARO) that combines IMS Health Booth X.622 strong scientific leadership and operational excellence to conduct innovative Contact: Nina Pruitt I Website: www.imshealth.com national and global clinical trials.Our scientific leaders have broad experience Email: [email protected] on study committees and are able to bring together, and work effectively with, IMS Health’s Clinical Trial Optimization Solutions is a leading global provider international networks of thought leaders. of information, technology and services dedicated to delivering predictable, optimized trial performance resulting in better: feasible protocol development; KCR S.A. Booth X.812 reliable country and site selection; optimal enrollment plans; predictable financial Contact:Joanna Lewandowska I Website: www.kcrcro.com outlays; actionable insights. Email: [email protected] KCR is a Contract Research Organization offering support in three main areas: Full IMI Education & Training Booth S.8 Service Model for Clinical Development Services (Phase II – IV), Functional Service Contact: Christa Janko I Website: www.emtrain.eu, www.on-course.eu Provider, and Non-interventional Studies. We operate in 18 countries and provide Email: [email protected] services to 12 out of top 20 Global Pharma companies on global or local contracts. IMI (www.imi.europa.com) has funded several projects dedicated to post-graduate Education and Training of scientists and professionals involved in biomedical Keyrus Biopharma Booth X.315 research. This will be relevant to al relevant sectors: academia, industry, regulatory Website: www.keyrusbiopharma.com bodies, patient organizations, political decision makers and others. Keyrus Biopharma, is a full-service provider of drug development services, with expertise in different medicinal products including biologic and cellular and tissue-based products. Keyrus Biopharma is offering services in project management, clinical monitoring, site management, regulatory affairs, medical writing, pharmacovigilance, biostatistics, data management. 62 EXHIBITOR SUMMARIES
Kinapse Booth X.223 MedDRA MSSO Booth X.300 Contact: Amanda Swain I Website: www.kinapse.com Contact: Brian O’Hare I Website: www.meddra.org Email: [email protected] Email: [email protected] We provide expert consulting and outsourcing services to the life sciences MedDRA is a clinically validated terminology used for encoding adverse events for industry. We collaborate with our clients to innovate for exceptional results. We the biopharmaceutical industry and regulators. The MSSO maintains MedDRA and are one global business with expert teams providing excellent services. Our 300 provides support services (e.g., training, data conversion, consulting) professionals worldwide ensure excellent client service on all our engagements. We are KINAPSE. Come and meet us. Medicademy Booth X.607 Contact: Tina Jensen I Website: www.medicademy.net LASER ANALYTICA Booth X.727 Email: [email protected] Contact: Emma Carroll I Website: www.la-ser.com Medicademy – Regulatory Affairs and Pharmacovigilance - Education, Seminars Email: [email protected] and Conferences! 23 modules offered in cooperation with the University of LASER ANALYTICA with offices in 9 countries spanning 3 continents provides Copenhagen, University of Southern Denmark and The Danish Health and strategic consulting and scientific research services to the healthcare technology Medicines Authority, can lead to: •Master Degree at the University of Copenhagen, industry. Offering a wide range of evidence-based solutions, proprietary research Denmark •Diploma •Individual Modules services, HEOR consulting capabilities, we support bringing safe and effective treatments to market Medicines Evaluation Unit Booth Y.512 Contact: David Rogers I Website: www.meu.org.uk Lindeq Booth X.518 Email: [email protected] Contact: Solveig Blomvik I Website:www.lindeq.com The MEU is one of the UK’s leading CRO, a facility where commitment to Email: [email protected] excellence is paramount. Possessing extensive pharmaceutical, scientific and Lindeq is provides solutions in pharmacovigilance, cosmetovigilance, clinical clinical expertise, within a state of the art 36 bed hospital based research facility. safety and medical device vigilance. Individual solutions include clinical safety The MEU is phase 1 accredited specialising in clinical trials in, Asthma, COPD, monitoring via approval process to post marketing, risk management, safety Cystic Fibrosis and Allergy. audits and IT solutions like web-based databases and quality management systems. Lindeq is ISO 9001-2008 certified. MEDIS RESEARCH GROUP Booth X.500 Creative Clinical Research (CCR) GmbH LORENZ Life Sciences Group Booth X.714 Contact: Martin Krainz & Dr. med. Joachim Linke, MD, MSc Contact: Alexander Stapf I Website: www.lorenz.cc Email: [email protected] & [email protected] Email: www.lorenz.cc/emailAlexander Stapf Website: www.medis-research.com & www.ccr-cro.com LORENZ is the most established provider of e-regulatory software and services MEDIS RESEARCH GROUP is a Berlin-based CRO partnership with a mission in the world, focused on submission management, labelling and tracking. The to provide clinical research services for the planning, conduct and analysis of products don’t require the purchase of continual services to get the job done. entire trial projects. CCR has extensive experience in developing value dossiers LORENZ’ solutions foster independence, empowering customers to develop their according to the AMNOG law in Germany and offers senior medical consultants own processes. for your drug development processes.
MakroCare Booth T.1 MonitorForHire.com Booth X.213 Contact: Abhinay Yarlagadda Contact: Scott Freedman I Website: www.monitorforhire.com Email: [email protected] Email: [email protected] MakroCare established in 1996 with USA as HQ is a global Development and MonitorForHire.com helps clinical trial sponsors locate independent CRAs Commercialization firm. MakroCare has 5 subsidiaries (Regulatory, CRO, SMO, anywhere in the world, fast, with nearly 5,000 registered & pre-qualified monitors Informatics and Commz) that support various aspects of Product Life Cycle. covering all therapeutic areas in 60 countries including the US, Europe, Asia & MakroCare leverages teams positioned in USA, UK, Europe, India, China, Singapore MENA. and Japan to optimize productivity and costs. Moravia Life Sciences Booth X.318 MasterControl Inc Booth Y.217 Email: [email protected] I Website: www.moravia.com Contact: Emily O’Driscoll I Website: www.mastercontrol. Moravia Life Sciences is a global translation services provider that helps you bring Email: [email protected] com your products to international markets. Founded in 1990, we are triple-certified Change Management/Implementation,Data Management,Document (ISO 9001, ISO 13485 and EN 15038) and rank among the top language services Management,Electronic Submissions,GCP Compliance,GLP Compliance,GMP providers globally. We are life sciences translation experts offering translations in Compliance,Quality Assurance/ Control,Stability Studies/Testing,Training over 120 languages. MasterControl produces software solutions that enable pharmaceutical companies to get their products to market faster, while reducing overall costs and increasing MyMedsandMe Limited Booth X.713 internal efficiency. MasterControl solutions include quality management, Contact: Andy Watson I Website:www.mymedsandme.com document management, submissions management, training management, Email: [email protected] supplier management, CAPA management, and more. MyMedsandMe has developed a solution to capture adverse event and product complaint information directly from both the public and healthcare professionals, Max Application s.r.l. Booth X.810 provided as software as a service. Information once captured is processed and Contact: Celine Rondi I Website: www.safetydrugs.it coded into industry standard E2B reports that can be transferred direct into Email: [email protected] safety or manufacturing databases. Max Application is a value-added company that has developed, according to GAMP 5 guidelines, SafetyDrugs, a complete adverse events case data NANOKINETIK Booth S.6 management and regulatory reporting module for pharmaceutical industry with Contact: Vito Strasberger I Website: www.nanokinetik.com a good price/quality ratio. Email:[email protected] We design and implement medicinal product databases, tracking tools and document management systems with the focus on pharmaceutical industry. Pharmaceutical companies and regulatory agencies are using our innovative web and mobile solution READY! to safely manage medicinal product information, activities, documents, and electronic submissions. EXHIBITOR SUMMARIES 63
NDA Group Booth X.701,X.800 PaediaCRO GmbH Booth X.722 Contact: John Reynolds I Website: www.ndareg.com Contact: Prof. Dr.med. Dr. rer. nat. Dr. h.c. mult. Dieter Adam Email: [email protected] Email: [email protected] I Website: www.PaediaCRO.eu NDA is Europe’s leading regulatory development, PV & HTA Consultancy, providing PaediaCRO – is your CRO for your product development in paediatric use. We will both small & large multi –national pharma companies with strategic advice & support you in the development of strategies and solutions for your products in operational support to get their medicines to market & keep them there. Our paediatric use. By using modern methods and technologies, e.g. -Dialysis for PK team comprises of experts from EU regulatory agencies, scientific committees, / PD, PaediaCRO increases recruitment by minimizing burden to the paediatric HTA bodies & leading pharma companies. patients.
NextDocs Booth X.301 ParagonRx Booth T.17 Contact: Patricia Basset I Website: www.nextdocs.com Contact: Tony Reynolds I Website: www.paragonrx.com Email: [email protected] Email: [email protected] NextDocs provides innovative document management and compliance solutions The ParagonRx process is the optimal pathway to detect & manage risk, gain including eTMF, regulatory document management, SOP management and regulatory approval, & ensure success of your product on the market. Our benefit- quality management systems which enable full compliance while automating risk management expertise, systematic methodologies, & standardized tools, processes, improving efficiency and reducing costs. NextDocs has over 100 along with services available through our affiliates at inVentiv Health, provide customers including 5 of the top 10 pharmaceutical companies. end-to-end support for our clients.
NNIT Booth Y.111,Y113,Y.210,Y.212 PAREXEL Booth X.321 Email: [email protected] I Website: nnit.com Contact: Julie Burgess I Website: www.parexel.com NNIT is one of Europe’s leading consultancies in the development, implementation, Email: [email protected] validation and operation of IT for the life sciences industry. They create value for PAREXEL’s Regulatory Information Management Business provides innovative their clients by treating their IT as if it were their own, and of course, they meet software and regulatory outsourcing solutions designed to support the regulatory the industry’s strictest regulatory requirements. business processes of life sciences companies. Our flagship product, LIQUENT InSight, is the proven market leading end-to-end, integrated Regulatory NonStop Recruitment Schweiz AG Booth Y.417 Information Management (RIM) platform. Contact: Martin Vagner I Website: www.nonstop-recruitment.com Email: [email protected] Paspartu Translation Services Booth Y.316 NonStop Recruitment helps both employers and professionals to develop, grow Contact: Diana Ieremia I Website: www.paspartu.gr and succeed – by putting the ‘right’ people in the ‘right’ roles with the ‘right’ Email: [email protected] companies. Our knowledge, professionalism and dedication brings a real focus to In the heart of medical translation - your one-stop translation provider for the delivering the right result, for clients and candidates alike. medical sector. We are an ISO certified, multilingual translation company catering for the medical industry since 2006, with over 100.000 translated pages, in most Novella Clinical Booth Y.604 EU and Asian languages, plus Arabic. Services - translation, localization, trials Contact: Michelle Nobel validation. Email: [email protected] NCR is one of the clinical research industry’s most reputable providers of PCG Solutions AB (Exhibiting under the name “Viedoc” ) Booth X.611 contract staffing, permanent recruitment and functional service provider (FSP) Contact: Sverre Bengtsson I Website: www.pharmaconsultinggroup.com programmes, having successfully placed personnel in more than 40 countries. Email: [email protected] Our team has a unique and impressive combination of clinical operations and EDC AS IT SHOULD BE; Viedoc is wonderfully intuitive, enabling efficient clinical resourcing experience. management of the clinical trial process. Focus on what you do best and let Viedoc help you document it. Running 500 projects in 56 countries, Viedoc is a Online Business Applications IncBooth X.211 well-established EDC system. Now in Viedoc 4, even easier. Viedoc is a blessing Contact: Joe Pierce I Website:www.irmsonline.com for the busy study site. Email: [email protected] Online Business Applications has been committed to providing advanced software Pharmaceuticals and Medical Devices Agency (PMDA) Booth X.704 solutions for the Pharmaceutical, Biotechnology, and Medical Device industries in Email: [email protected] I Website: www.pmda.go.jp the areas of Medical Communications and Drug Safety. We utilize proven leading- The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese edge technologies, anticipate our clients’ needs, and deliver solutions that exceed regulatory agency that reviews applications for marketing approval of expectations. pharmaceuticals and medical devices, monitors product safety, and provides financial relief to people suffering from adverse drug reactions, in collaboration Oracle Health Sciences Booth X.621,X.623 with the Ministry of Health, Labour and Welfare. Contact: Kate Andrews I Website: www.oracle.com/healthsciences Email: [email protected] PharmAdvice ApS Booth Y.213 Oracle Health Sciences is a leading strategic software solutions provider to Contact: Janne Fehrn- Christensen I Website: www.PharmAdvice.dk pharmaceutical, biotechnology, medical device and healthcare organizations. Email: [email protected] We are transforming clinical R&D from pipeline to patient; helping organizations PharmAdvice is an independent Danish Consultancy company established in improve patient outcomes by providing actionable insights from aggregated 2002. We have many years of experience within EU Regulatory Affairs and can clinical and healthcare data while optimizing clinical trial efficiency and offer services within Regulatory Affairs and Pharmacovigilance to companies productivity. within the Pharmaceutical industry.
Packaging Coordinators Inc. Booth Y.606 Contact: CraigTaylor I Website:www.pciservices.com Email: [email protected] PCI is the global leader for packaging services, a trusted partner to the world’s largest and most successful pharmaceutical firms. We offer services from early phase clinical studies to commercial launch and ongoing supply. Clients view us as an extension of their business, a collaborative partner, with the shared goal of improving patients’ lives. 64 EXHIBITOR SUMMARIES
PharmaForms GmbH / Amedon GmbH Booth X.705 PrimeVigilance Ltd Booth Y.411, Y.510 Contact: Ulrich Hönig / Bernhard Brandewiede Contact: Nigel Amphlett / Florence Denance Habek Email: [email protected] Website: www.halbach.com Email: [email protected] PharmaForms and AMEDON provide hybrid Data Capture Solutions adapted [email protected] to the requirements of the study design.Capture technology: based on paper, Website: www.primevigilance.com dotforms® digital pen, print & services for Qol-Questionnaires/eCOA, high end PrimeVigilance is a global service provider dedicated to deliver high quality, EDC-tools.Choosing the right methods according to user requirements help compliant and cost-effective Pharmacovigilance & Medical Information. optimize acceptance and achieve better data quality. PrimeVigilance sits between large CROs who focus on clinical trial and small service providers who lack critical mass,expertise or international presence Pharmalink Consulting Booth X.320, X.322 needed for reliable scientific & safety services Contact: Kevin O’Toole I Website: www.pharmalinkconsulting.com Email: ko’[email protected] ProClinical Limited Booth Y.612 Pharmalink Consulting is the healthcare industry’s number one choice for Contact: Richard Thomas Regulatory Affairs sustainable outsourcing. Regardless of project size or Email: [email protected] timescale, Pharmalink can fulfill any Regulatory Affairs requirement.From filing Established in 2006, at ProClinical, we recruit professionals into the Life Science submissions and post-licensing activities to the management of full-scale industry working with leading Pharmaceutical, Biopharmaceutical, CRO and compliance programmes, we are the experts in all areas. With eight offices in Medical Devices companies with professionalism, discretion and efficiency. three continents and consultants on the ground in 115 countries supplying market Operating on a pan-European basis, we recruit for companies in the both the UK leading intelligence. and EU. We provide temporary contractors as well as permanent staff, and we also operate on a retained search basis for senior vacancies. Pharmathen S.A. Booth X.214 Contact: Dr. Dimitris Antoniadis I Website: www.pharmathen.gr ProductLife Group Booth X.519, X.521 Email: [email protected] Contact: Adam Sherlock I Website: www.productlife-group.com Pharmathen, located in Athens, Greece, was founded in 1969 as a private Email: [email protected] pharmaceutical company, and is focused on developing and marketing innovative Adam ProductLife Group is the leading, proven and trusted Pan-European health care products.Today, the in-house development products of Pharmathen are specialist-outsourcing-services provider for the regulatory, safety and quality registered in all major EU markets and licensed out to the largest pharmaceutical functions of the life sciences and cosmetics industries. Through the optimum companies in Europe, Canada, Australia, South Africa and the United States. deployment of people and intellectual assets, we enable clients to achieve greater R&D effectiveness and efficiency. PharmaTimes Booth T.5 Contact: Luci Chalk I Website: www.pharmatimes.com Quality and Compliance Consulting, Inc. Booth X.711 Email: [email protected] Contact: Jason Bertram I Website: www.qc2.com The PharmaTimes portfolio includes PharmaTimes Magazine for independent Email: [email protected] reporting; PharmaTimes Online; two free online e-news services delivered by QC2 provides worldwide audit and consulting services, including: GCP, GLP, and email including World and Clinical news; PharmaTimes business meetings, where cGMP Audits; Bioanalytical Laboratory Audits; Clinical Pathology Laboratory thought-leaders meet to discuss the issues of the day; and a unique series of Audits; Sponsor, CRO, and Vendor Audits; Computerized System Validation career development, competency-based competitions in marketing, clinical, sales Audits; Standard Operating Procedures Review and Preparation; GCP, GLP, QA, and business leadership. and SOP Training; and Consulting.
PHARMIWEB.COM Booth X.115 QUMAS Booth X.627 Contact: Vincent Lody I Website: www.pharmiweb.com Contact: Csaba Bujna I Website: www.qumas.com Email: [email protected] Email: [email protected] PharmiWeb.com is the leading jobs and news portal for the pharmaceutical, QUMAS, a leader in Compliance & Quality Management Solutions for LS, with 270+ biotech and life sciences sector. Constantly updated with the latest events, global customer deployments & domain expertise in regulatory compliance since features, news and thousands of jobs from all the leading employers in the sector. 1994. QUMAS provides software solutions for Electronic Document Management PharmiWeb.com is brought to you by innovative online publisher and e-business (SOPs, QA Docs), Electronic Process Management (CAPA, Deviation, Change solutions provider, PharmiWeb Solutions. Control, Audit), eCTD & Submission Management.
PHT Corporation Booth X.311 Real Regulatory Ltd Booth X.412 Contact: Valdo Arnera I Website: www.phtcorp.com Contact: Patrick Creed I Website: www.realregulatory.com Email: [email protected] Email: [email protected] PHT Corp helps pharmaceutical companies conduct trials with greater confidence, Real Regulatory is an independent consultancy and outsourcing firm which ease and accuracy. Proven PHT eCOA Systems collect patient-driven eData via specialises in Regulatory Affairs in the pharmaceutical, medical device and related smartphones, tablets and the web. PHT has helped trial sponsors in 600+ global industries. Our highly experienced team of consultants can provide immediate trials resulting in 16 regulatory approvals. Visit phtcorp.com for more information. hands-on assistance with clinical development, registration and lifecycle Follow PHT on LinkedIn, Twitter and YouTube. management
Pope Woodhead & Associates Ltd Booth Y.317 Real Staffing Zurich Booth Y.307 Contact: Laura Waite / Marianne Cassidy Contact: Gareth Rose I Website: www.realstaffing.com Email: [email protected] Email: [email protected] [email protected] Real is a global leader in the provision of pharma, biotech and medical devices Website: www.popewoodhead.com recruitment services and has one of the largest networks of specialist recruiters We are a leading consultancy providing innovative solutions and integrated globally. By recognising talent and valuing relationships we are able to consistently thinking in benefit-risk (assessment, communication and evaluation), specialising deliver local, global and industry expertise which in turn ensures success time in after time. • Risk management, drug safety and regulatory strategy • Outcomes studies/registry implementation • Value strategy and market access • Capability building EXHIBITOR SUMMARIES 65
Regulatory Pharma Net Booth X.615 SanaClis s.r.o. Booth X.806 Contact: Dr Anita Falezza I Website: www.regulatorypharmanet.com Contact: Adriana Kuzmisinova I Website: www.sanaclis.eu Email: [email protected] Email: [email protected] Regulatory Pharma Net (RPN) offers full regulatory affairs assistance during the SanaClis is privately owned CRO founded in Slovakia in 2000 by the team of whole development process, registration and maintenance phase of a medicinal professionals. Operates in 10 CEE countries: EU : Slovakia, Czech Republic, product. The highly qualified RPN team works with its clients, complementing Hungary, Estonia, Latvia, Lithuania / Non-EU : Ukraine, Russia, Belarus, Georgia. their skill-sets and resources to help them overcome obstacles in the management Each office is ISO 9001 certified. Successfully passed 49 GCP / GMP sponsor of regulatory affairs activities. audits and 8 GCP/GMP inspections Rating by reputable business rating agency „Creditreform“: „Establishing of business connection is allowed“ Regulatory House Booth X.804 Contact: Jana Prossero I Website:www.regulatoryhouse.com Schlafender Hase GmbH Booth X.207 Email: [email protected] Contact: Marlena Loncina I Website: www.text-verification.com Regulatory House is focused to provide proffesional regulatory strategy and Email: [email protected] services to pharmaceutical, cosmetic, veterinary and medical device companies in The Text Verification Tool® (TVT) developed by Schlafender Hase GmbH is an all areas and aspects of EU regulation in all of the EU markets. skype: Regulatory easy-to-use proofreading software. It helps global pharmaceutical leaders to save House time, improve quality, avoid embarrassment and legal costs that can result from avoidable mistakes. TVT compares text files in any language and supports all RJR Consulting, Inc and ADS Insight Booth X.204 standard file types, including XML. Contact: Jennifer Soronen I Website: www.rjr-consulting.com Email: [email protected] SGS Life Science Services Booth Y.117 RJR Consulting is a global regulatory consulting firm assisting companies, Contact: Claire Rupprecht I Website: www.sgs.com/lifescience governments and organizations with their regulatory affairs in the Life Sciences Email: [email protected] Industry. Our consulting team has over 200 collective years of life sciences SGS Life Science Services is a leading contract service organization providing industry experience and provides assistance to companies of all sizes, including clinical research, analytical development, biologics characterization, biosafety, and start-ups, fortune 100 companies and everyone in between. With headquarters in quality control testing. Delivering solutions for bio-pharmaceutical companies, Ohio, we have international offices and/or affiliate partners throughout Canada, SGS provides clinical trial management (Phase I to IV) services encompassing the EU, Eastern Europe and Russia, Latin America, Asia, the Middle East and South clinical project management and monitoring, PK/PD Simulation & Modeling Africa. services, data management, biostatistics, and regulatory consultancy. ADS Insight is a specialized public affairs consultancy in the heart of Europe with expertise in the healthcare, environment, transport and energy sectors. Sharp Clinical Services Booth Y.404 Our dynamic, versatile and competent team together with our dedication to our Contact: Luke Beedle I Website: www.sharpservices.com clients is what makes us successful. With over 12 years in the business, our partner Email:[email protected] company in the US, RJR Consulting, and several affiliate offices across Europe, Sharp Clinical Services are a leading provider of clinical supply chain services we have managed to maintain long-lasting and fruitful relations with our clients including product development & manufacture, packing, labeling, storage & In healthcare our qualified team will guide you through the EU and will find a distribution and QP audit & release services. Our experienced project management tailored service for your needs. & operational teams bring years of experience in producing and managing clinical supply chains across the Globe. RWS Translations Booth Y.312 Contact: Charles Morris-Denholm I Website: www.rws.com Tarius A/S Booth X.410 Email: [email protected] Contact: Nina Lindholst I Website:www.tarius.com Medical translation specialist RWS helps clients through their product life cycle Email: [email protected] from research and clinical trials through to patient reported outcomes, marketing Tarius® Web Portals provide hands-on answers to your global regulatory authorisation, pharmacovigilance and post-marketing surveillance across their FAQ’s. Subscribing to Tarius means online access to regulatory information on international markets. Specialist translators and strict quality procedures ensure Human Drugs, Biologics, Medical Devices and IVDs across 85 countries/regions. top quality translations. Customize your subscription to match your needs. It’s “Google-like”, hassle-free and updated daily. RxLogix Corporation Booth X.423 Contact: Shalini Modi I Website: www.rxlogix.com The Conference Forum Booth Y.717 Email: [email protected] Contact: Meredith Sands / Valerie Bowling RxLogix software and consulting services assist your Pharmacovigilance and Risk Email: [email protected]/[email protected] Management departments work more efficiently. We match the best practice Website: www.theconferenceforum.org business processes to the best-in-breed technologies to deliver solutions ranging The Conference Forum is the organizer behind some of the most influential life from software, critical metrics, to full safety system implementation of Oracle science conferences in the United States including Disruptive Innovations to Argus Safety Suite tm Advance Clinical Trials, Mobile in Clinical Trials, New Paradigms to Fund Biotech, Drug Delivery Partnering, Global Clinical Trials, Patients as Partners, Chief Medical Samarind Limited Booth X.720 Officer Summit for Emerging Biotechs and more. Contact: Ian Crone I Website: www.samarindrms.com Email: [email protected] The Regulatory Affairs Company Booth Y.413 Samarind is an award winning software vendor in the global Regulatory Contact: Sarah Middleton I Website: www.tctcgroup.com Information Management arena, and a leading provider of xEVMPD software - Email: [email protected] with a roadmap to ISO IDMP for 2015. Samarind RMS is an innovative ‘unified’ The RA Company™ (TRAC) give expert regulatory advice to pharmaceutical & regulatory information management database with integrated submissions biotech companies in order to gain approval for their products. TRAC excels in tracking, xEVMPD, eCTD and EDMS tools, superbly flexible reporting facilities orphan drug research and device/drug combination trials which often do not have and excellent security. The system is available as an on-premise solution or as a a classical roadmap to market. The TRAC gained marketing approval for the first software-as-a-service (SaaS) model. gene therapy product in the EU. 66 EXHIBITOR SUMMARIES
The Uppsala Monitoring Centre Booth X.712 Veeva SystemsBooth X.814, X.715 Contact: Mats Persson I Website: www.umc-products.com Contact: Carole Rabeony I Website: eu.veeva.com Email: [email protected] Email: [email protected] The Uppsala Monitoring Centre (UMC) offers tools & resources to enhance Clinical Veeva Systems is a leader in cloud-based software for the global life sciences Trials & Drug Safety Operations. UMC is the maintenance organization for the industry. Committed to innovation, product excellence and customer success, WHO Drug Dictionary Enhanced and WHO Herbal Dictionary, used globally for Veeva has more than 170 customers, ranging from the world’s largest coding and analyses of concomitant medication data. pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is headquartered in the US with offices worldwide. The Weinberg Group Booth X.200 Contact: Jeff Antos I Website: www.weinberggroup.com XClinical GmbH Booth X.314 Email: [email protected] Contact: Philippe Verplancke I Website: www.xclinical.com For 30 years, The Weinberg Group, headquartered in Washington, DC, has served Email: [email protected] the global pharma industry, providing FDA regulatory and compliance support. XClinical GmbH, Munich Germany, developes and distributes MARVIN a Though much of our work is project-based, for some clients, we assume all comprehensive and CDISC ODM-certified EDC-, CDM- and CTM-System for phase regulatory responsibilities for a fixed monthly fee. This new service is called ORA I-IV clinical trials as well as post-marketing- and register studies. Our eCRF design SM, Outsourced Regulatory Affairs. tool STUDY COMPOSER offers and intuitive graphic user interface for setting up eCRF, edit checks and dynamic elements. TransPerfect Booth X.304, X.306 Email: [email protected] I Website: www.transperfect.com Xendo B.V. Booth X.813 TransPerfect is the leading provider of language services and technology solutions Contact: Robert Schultz-Heienbrok I Website: www.xendo.com to organisations involved in drug development. Our services include translation, Email: [email protected] website localisation, and linguistic validation, as well as eTMF and other e-clinical CC: [email protected] technology solutions. TransPerfect has over 85 offices globally. lifesciences. Xendo is a leading, independent consultancy and project management transperfect.com organization for the pharmaceutical and medical device industry (www.xendo. com). Xendo has recently merged with Vigilex, a pharmacovigilance consultancy. Trilogy Writing and Consutling GmbH Booth X.218 Visit our booth for more information on our service range and to download our Contact: Sowmya Kalaivanan I Website: www.trilogywriting.com new App for Variation Classification for free. Email: [email protected] Trilogy is a medical writing consultancy focused entirely on medical writing and medical writing training, offering the full range of regulatory clinical documentation across all therapeutic areas. Two in one: Exhibit at the Clinical Forum Truven Health Analytics Booth X.310 and EuroMeeting 2015. Don’t miss this Email: [email protected] I Website: truvenhealth.com opportunity to reach your target audience At Truven Health Analytics, we’re dedicated to delivering the answers our clients need to improve healthcare quality and access, and reduce costs. Our unmatched in Paris 2015! data assets, technology, analytic expertise, and comprehensive perspective have served hospitals and clinicians, employers and health plans, state and federal Showcase your company’s products and services to medicines development government, life sciences researchers, and policymakers for more than 30 years. professionals attending the Clinical Forum and the full audience of the EuroMeeting, in one shared exhibition hall. United BioSource Corporation (UBC) Booth Y.619 Contact: Brett Huselton I Website: ubc.com The Clinical Forum and the EuroMeeting will provide the opportunity Email: [email protected] to interact with a truly global audience of qualified professionals in the UBC unites unsurpassed experience in generating real-world evidence of product pharmaceutical and biotechnology industries, contract service organisations, safety, value, and effectiveness, with the strength of its parent company, Express regulatory agencies, health ministries, patient organisations and universities Scripts, one of the nation’s largest healthcare companies. UBC leads the market in throughout Europe and worldwide. providing integrated, comprehensive periapproval, safety, and commercialization services.
Universal Medica Group Booth X.323 Contact: Rafi Mardachti I Website: www.universalmedica.com Email: [email protected] Universal Medica Group, founded in 2000, is a global service provider focused on health management. Our expert team assists the pharmaceutical industry in all aspects of Medical Information, Pharmacovigilance, Crisis Management, Epidemiology and Market Access. Our outsourcing offers cover Europe, North America, Asia, and the Middle East.
Valos s.r.l. Booth X.111 Contact: Dmitri Petratchenko I Website: www.valos.it Email: [email protected] VALOS is a company offering comprehensive biostatistics, epidemiology, outcome research, comparative effectiveness research, statistical programming and data management services for Phase I-IV and retrospective studies focusing on Sponsor’s needs, and working as a part of its team using processes that match Sponsor’s systems. 67
A special thank you to our GOLD Level Supporter
Visit ORACLE at Booth # X.621/X.623
A special thank you to our BRONZE Level Supporter
Visit Truven Health Analytics at Booth # X.310 8 t h A n n u a l Clinical Forum P a r i s 2015
14-15 April 2015 Palais des Congrès, Paris, France 69 70
VOLUNTEER CORNER AT THE DIA BOOTH
GET INFORMED | GET INVOLVED DIA Booth X504 | Tuesday, 25 March 12:00 – Thursday, 27 March 16:00 Pick up your community ribbons, view a demonstration of the global community communications tool ConneX, and find out how to get more involved in DIA and why you should go for it: - 35 communities exclusively for DIA members - Network with specialists you wouldn’t normally meet - Keep your finger on the pulse of hot topics and shared learning - Easier access to speaking opportunities
MEET THE VOLUNTEERS Key DIA Volunteers and Community Leaders are ready to meet and share their experiences with you at the DIA Booth during conference refreshment and lunch breaks. While finding out about upcoming DIA events and learning about new European Membership benefits, use the opportunity to talk to the experts. Hear first-hand what volunteering did for them – and what it can do for you! 71 72 R P L A NS V FLOO AC 73 R P L A NS V FLOO AC 74 26th annual euromeeting SESSION PLAN
Tuesday, 25 March 2014 Tuesday, 25 March 2014 Tuesday, 25 March 2014
09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials
11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting
14:00-17:15 Plenary 14:00-17:15 Plenary 14:00-17:15 Plenary 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 Theme 6 Theme 7 Theme 9 Theme 10 Theme 13 Theme 14 Theme 16
Knowledge Management Benefit/Risk Management and The Role of Transparency and Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Special Populations Personalised Medicines Innovation in Clinical Research eClinical: Reaching Out Involving and Informing Patients Globalisation/ Inspections Innovation in R&D Models and Regulatory/Competitive Lifecycle Approach Ethics: Legal Perspectives Sessions Intelligence
Wednesday, 26 March 2014 Wednesday, 26 March 2014 Wednesday, 26 March 2014
Session 0601 Session 1601 Session 0101/0301 Session 0201 Session 0101/0301 Session 0401 Session 0701 Session 1001 Session 1301 Session 1 Session 0501 The Importance for All to Adopt the New Session 0901 What Can Regulatory Intelligence Making the Pharmacovigilance Creating an Adaptive Pathway for Making the Pharmacovigilance Paediatric Rewards- where do we eTrial Master File (eTMF): Regulatory Harmonisation and Transparency – is clearing the past 09:00-10:30 Translation of Personalised Medicine Concepts Paradigm in Clinical Research: Patients as Partners in Clinical Research Groups Learn from Experts in Legislation Work – a temperature check Medicines to Patients Legislation Work – a temperature check Stand? Clinical in the Clouds? Regulatory Convergance- an update clouding the future? Introductory session Knowledge Management?
Room B Level O2 Room E2 Level OE Room B Level O2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room 6AB Level O1 Session 1602 Session 0102 Session 0202 Session 1002 Session 0302 Session 0702 Session 0902 Session 1302 Session 1402 The Practical Aspects of the Session 2 Hurdles to Overcome to Ensure How do Payers View Current Session 0402 Session 0502 Surviving Safety and Quality Thinking Beyond Old eClinical: Faster, better, high-quality trial Patient Empowerment: Opportunities Disclosure of Clinical Trial Data- Innovation through Public Private Regulatory Intelligence 11:00-12:30 Regulatory Success for the Next Developments in the HTA and Regulatory Latest Developments in Pediatrics From Biomarkers to Companion Diagnostics Inspections in Pharmacovigilance Boundaries set-up and conduct and challenges what does the future hold? Partnership Collaborations Function-Organisation and Generation of Products Environment? the Era of Globalisation Processes Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0603 Session 0203 Session 0403 Session 0503 Session 0703 Session 1303 Session 1403 Session 1603 Session 3 Session 0103 The New Paradigm in Clinical Research: Session 1003 Established Interactions throughout the Developing Medicinal Products for Older Health Economic Aspects of eClinical: From case decision to Early Access to Unauthorised Innovation in Biomarkers and Regulatory Intelligence Input into 14:00-15:30 Regulatory Town Hall Meeting The case for developing new roles, skills Global Development and Supply Registration Pathway People –getting on track Personalised Medicine strategic alignment Medicines Disease Stratification Development Strategies and competencies
Room B Level O2 Room G Level U2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0604 Session 1004 Session 1604 Session 0104 Session 0204 Session 0304 Session 0504 Session 0704 Session 0904 Session 1304 Session 1404 Session 1704 Session 4 Optimising Clinical Research: Which GCP Inspections – international Regulatory Intelligence in Practice How to Get Ready for the New Clinical Databases, Registries and other Current Industry Practice for Benefit/ The Societal Perspective on Data Integration: Reaching the next Efficient Use of Social Media to Work Unintended Implications of Innovation in Clinical Trial Design The Case For and Against a Reform 16:00-17:30 infracturial and business relationship changes collaboration and harmonisation - how regulatory authorities inform Trials Legislation Data Capture Tools Risk Governance Personalised Medicine level of efficiency with e-Patients Transparency and Evaluation of the Pharmaceutical Legislation do we need to consider? efforts about decision making
Room E1 Level OE Room G Level U2 Room E2 Level OE Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1 Room H Level U2 Thursday, 27 March 2014 Thursday, 27 March 2014 Thursday, 27 March 2014
Theme 1 Theme 2 Theme 3 Theme 8 Theme 11 Theme 6 Theme 12 Theme 15 Theme 10 Theme 13 Theme 14
eHealth: Innovation in Benefit/Risk Management and Regulation of Medical Devices and Pharmaceutical Quality in the 21st New and Known Active Substances - The Role of Transparency and Hot Topics/Stand Alone Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Healthcare and its Impact on Innovation in Clinical Research Globalisation/ Inspections Innovation in R&D Models Lifecycle Approach Combination Products Century how to fit the rules to needs Ethics: Legal Perspectives Sessions Sessions Industry
Session 0105 Session 1005 Session 1705 Session 0305 Session 0805 Session 0605 Session 1205 Session 1505 Session 1305 Session 1405 Session 5 Biosimilars- building in European Session 0205 Global Submission and Review The Changing Face of the EMA Transparency in the Pharmaceutical European Commission’s eHealth Innovative Methodologies Used Quality by Design (QbD) and Innovation in New Active Substances and Known Active Transparency of Payments to the Innovation in Drug Delivery Systems 09:00-10:30 foundations to achieve Global Marketing Authorisation and Beyond Strategy - how rapidly innovation Inside and Out: An overview of the Sector – what have we learned? Action Plan 2012-2020 in Enhancing Quality Development and Manufacturing Substances – designation, implications Healthcare Sector and Compliance Harmonisation can reach global markets new structure and expectations
Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room I Level U2 Session 1006 Session 0106 Session 0606 Session 1306 Session 0306 Session 0806 Session 1106 Session 1206 Panel Discussion: Regulation 2025 Session 1406 Session 1706 Session 6 Challenges and Opportunities in Workshop: The New Paradigm in Clinical Session 1506 Diclosure of Safety Data: Can PRAC, Moving from Risk Management to Interoperability for Healthcare The New Regulatory Outlook for Devices, Experience with Implementation of – stakeholder vision for the future Innovation in Preclinical and Japanese Regulatory Session: 11:00-12:30 the Implementation of the Falsified Research: Stakeholder perspectives for a How to Realise Biosimilars’ Full Potential patients and industry perspective be Benefit/Risk Management Planning Providers across the EU IVDs and Combination Products the Lifecycle Approach of the global regulatory framwork Clinical Safety Sciences PMDA Update Medicines Directive rational process reconciled? between now and 2025 Room E1 Level OE Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room G Level U2
Session LB01 Session LB01 12:45-13:45 Briefing on ATMPs
Room 12 Level U2 Session 1707 Session 0207 Session 0307 Session 1007 Session 0107 Session 1107 Session 0607 Session 1507 Session 1307 Session 1407 GCP Hot Topic 1- The Use of Session 7 How Do We Bring the Patient’s Voice Periodic Benefit/Risk Evaluation Session 0807 Current Status and Future Optimising Regulatory Operations Key Considerations for Development and Systematic Approaches to Deliver Quality: How to Overcome the Obstacles in Product Liability, Off-Label Use Non-Clinical Development Strategies Electronic Health Records by 14:00-15:30 into the Discussion? How do we ensure Reporting – Has it achieved what it Big Data, eHealth and Taxonomy Challenges of the Asian Regulatory through Use of Information Technology Approval of Companion Diagnostics Learn from the Experts! Patients’ Access and Patient Information Leaflets for Biosimilar Monoclonal Antibodies Investigators and Sponsors for that all the right voices are heard? set out to do? Environment Clinical Research Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level O1 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0308 Session 0208 Session 1108 Session 0608 Session 1208 Session 1508 Session 1008 Session 8 Risk Minimisation and its Effectiveness – Session 0808 Session 1408 Session 1708 Are Our Healthcare Systems Ready to Clinical Investigations for Medical Devices The Brave New World of Digital Data: What are Challenges and Opportunities for Risk Perception, Risk Management and Known Regulatory Simplification: Vision, 16:00-17:30 what is state of the art and The Role of Social Media in Healthcare Pharma Industry Incentive Systems GCP Hot Topic 2 Support These Approaches? and Combination Products the new ethical and legal questions? Pharmaceutical Quality Active Substances oxymoron, or ‘mission impossible’? what is realistic?
Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room NO Level O1 Room 6AB Level O1 26th annual euromeeting SESSION PLAN 75
Tuesday, 25 March 2014 Tuesday, 25 March 2014 Tuesday, 25 March 2014
09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials
11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting
14:00-17:15 Plenary 14:00-17:15 Plenary 14:00-17:15 Plenary 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 Theme 6 Theme 7 Theme 9 Theme 10 Theme 13 Theme 14 Theme 16
Knowledge Management Benefit/Risk Management and The Role of Transparency and Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Special Populations Personalised Medicines Innovation in Clinical Research eClinical: Reaching Out Involving and Informing Patients Globalisation/ Inspections Innovation in R&D Models and Regulatory/Competitive Lifecycle Approach Ethics: Legal Perspectives Sessions Intelligence
Wednesday, 26 March 2014 Wednesday, 26 March 2014 Wednesday, 26 March 2014
Session 0601 Session 1601 Session 0101/0301 Session 0201 Session 0101/0301 Session 0401 Session 0701 Session 1001 Session 1301 Session 1 Session 0501 The Importance for All to Adopt the New Session 0901 What Can Regulatory Intelligence Making the Pharmacovigilance Creating an Adaptive Pathway for Making the Pharmacovigilance Paediatric Rewards- where do we eTrial Master File (eTMF): Regulatory Harmonisation and Transparency – is clearing the past 09:00-10:30 Translation of Personalised Medicine Concepts Paradigm in Clinical Research: Patients as Partners in Clinical Research Groups Learn from Experts in Legislation Work – a temperature check Medicines to Patients Legislation Work – a temperature check Stand? Clinical in the Clouds? Regulatory Convergance- an update clouding the future? Introductory session Knowledge Management?
Room B Level O2 Room E2 Level OE Room B Level O2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room 6AB Level O1 Session 1602 Session 0102 Session 0202 Session 1002 Session 0302 Session 0702 Session 0902 Session 1302 Session 1402 The Practical Aspects of the Session 2 Hurdles to Overcome to Ensure How do Payers View Current Session 0402 Session 0502 Surviving Safety and Quality Thinking Beyond Old eClinical: Faster, better, high-quality trial Patient Empowerment: Opportunities Disclosure of Clinical Trial Data- Innovation through Public Private Regulatory Intelligence 11:00-12:30 Regulatory Success for the Next Developments in the HTA and Regulatory Latest Developments in Pediatrics From Biomarkers to Companion Diagnostics Inspections in Pharmacovigilance Boundaries set-up and conduct and challenges what does the future hold? Partnership Collaborations Function-Organisation and Generation of Products Environment? the Era of Globalisation Processes Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0603 Session 0203 Session 0403 Session 0503 Session 0703 Session 1303 Session 1403 Session 1603 Session 3 Session 0103 The New Paradigm in Clinical Research: Session 1003 Established Interactions throughout the Developing Medicinal Products for Older Health Economic Aspects of eClinical: From case decision to Early Access to Unauthorised Innovation in Biomarkers and Regulatory Intelligence Input into 14:00-15:30 Regulatory Town Hall Meeting The case for developing new roles, skills Global Development and Supply Registration Pathway People –getting on track Personalised Medicine strategic alignment Medicines Disease Stratification Development Strategies and competencies
Room B Level O2 Room G Level U2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0604 Session 1004 Session 1604 Session 0104 Session 0204 Session 0304 Session 0504 Session 0704 Session 0904 Session 1304 Session 1404 Session 1704 Session 4 Optimising Clinical Research: Which GCP Inspections – international Regulatory Intelligence in Practice How to Get Ready for the New Clinical Databases, Registries and other Current Industry Practice for Benefit/ The Societal Perspective on Data Integration: Reaching the next Efficient Use of Social Media to Work Unintended Implications of Innovation in Clinical Trial Design The Case For and Against a Reform 16:00-17:30 infracturial and business relationship changes collaboration and harmonisation - how regulatory authorities inform Trials Legislation Data Capture Tools Risk Governance Personalised Medicine level of efficiency with e-Patients Transparency and Evaluation of the Pharmaceutical Legislation do we need to consider? efforts about decision making
Room E1 Level OE Room G Level U2 Room E2 Level OE Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1 Room H Level U2 Thursday, 27 March 2014 Thursday, 27 March 2014 Thursday, 27 March 2014
Theme 1 Theme 2 Theme 3 Theme 8 Theme 11 Theme 6 Theme 12 Theme 15 Theme 10 Theme 13 Theme 14 eHealth: Innovation in Benefit/Risk Management and Regulation of Medical Devices and Pharmaceutical Quality in the 21st New and Known Active Substances - The Role of Transparency and Hot Topics/Stand Alone Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Healthcare and its Impact on Innovation in Clinical Research Globalisation/ Inspections Innovation in R&D Models Lifecycle Approach Combination Products Century how to fit the rules to needs Ethics: Legal Perspectives Sessions Sessions Industry
Session 0105 Session 1005 Session 1705 Session 0305 Session 0805 Session 0605 Session 1205 Session 1505 Session 1305 Session 1405 Session 5 Biosimilars- building in European Session 0205 Global Submission and Review The Changing Face of the EMA Transparency in the Pharmaceutical European Commission’s eHealth Innovative Methodologies Used Quality by Design (QbD) and Innovation in New Active Substances and Known Active Transparency of Payments to the Innovation in Drug Delivery Systems 09:00-10:30 foundations to achieve Global Marketing Authorisation and Beyond Strategy - how rapidly innovation Inside and Out: An overview of the Sector – what have we learned? Action Plan 2012-2020 in Enhancing Quality Development and Manufacturing Substances – designation, implications Healthcare Sector and Compliance Harmonisation can reach global markets new structure and expectations
Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room I Level U2 Session 1006 Session 0106 Session 0606 Session 1306 Session 0306 Session 0806 Session 1106 Session 1206 Panel Discussion: Regulation 2025 Session 1406 Session 1706 Session 6 Challenges and Opportunities in Workshop: The New Paradigm in Clinical Session 1506 Diclosure of Safety Data: Can PRAC, Moving from Risk Management to Interoperability for Healthcare The New Regulatory Outlook for Devices, Experience with Implementation of – stakeholder vision for the future Innovation in Preclinical and Japanese Regulatory Session: 11:00-12:30 the Implementation of the Falsified Research: Stakeholder perspectives for a How to Realise Biosimilars’ Full Potential patients and industry perspective be Benefit/Risk Management Planning Providers across the EU IVDs and Combination Products the Lifecycle Approach of the global regulatory framwork Clinical Safety Sciences PMDA Update Medicines Directive rational process reconciled? between now and 2025 Room E1 Level OE Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room G Level U2
Session LB01 Session LB01 12:45-13:45 Briefing on ATMPs
Room 12 Level U2 Session 1707 Session 0207 Session 0307 Session 1007 Session 0107 Session 1107 Session 0607 Session 1507 Session 1307 Session 1407 GCP Hot Topic 1- The Use of Session 7 How Do We Bring the Patient’s Voice Periodic Benefit/Risk Evaluation Session 0807 Current Status and Future Optimising Regulatory Operations Key Considerations for Development and Systematic Approaches to Deliver Quality: How to Overcome the Obstacles in Product Liability, Off-Label Use Non-Clinical Development Strategies Electronic Health Records by 14:00-15:30 into the Discussion? How do we ensure Reporting – Has it achieved what it Big Data, eHealth and Taxonomy Challenges of the Asian Regulatory through Use of Information Technology Approval of Companion Diagnostics Learn from the Experts! Patients’ Access and Patient Information Leaflets for Biosimilar Monoclonal Antibodies Investigators and Sponsors for that all the right voices are heard? set out to do? Environment Clinical Research Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level O1 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0308 Session 0208 Session 1108 Session 0608 Session 1208 Session 1508 Session 1008 Session 8 Risk Minimisation and its Effectiveness – Session 0808 Session 1408 Session 1708 Are Our Healthcare Systems Ready to Clinical Investigations for Medical Devices The Brave New World of Digital Data: What are Challenges and Opportunities for Risk Perception, Risk Management and Known Regulatory Simplification: Vision, 16:00-17:30 what is state of the art and The Role of Social Media in Healthcare Pharma Industry Incentive Systems GCP Hot Topic 2 Support These Approaches? and Combination Products the new ethical and legal questions? Pharmaceutical Quality Active Substances oxymoron, or ‘mission impossible’? what is realistic?
Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room NO Level O1 Room 6AB Level O1 26th annual euromeeting SESSION PLAN 76
Tuesday, 25 March 2014 Tuesday, 25 March 2014 Tuesday, 25 March 2014
09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials 09:00-12:30 Pre-conference Tutorials
11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting 11:00-12:30 Austria Satellite Meeting
14:00-17:15 Plenary 14:00-17:15 Plenary 14:00-17:15 Plenary 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception 17:30-19:00 EuroMeeting Grand Opening Reception Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 Theme 6 Theme 7 Theme 9 Theme 10 Theme 13 Theme 14 Theme 16
Knowledge Management Benefit/Risk Management and The Role of Transparency and Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Special Populations Personalised Medicines Innovation in Clinical Research eClinical: Reaching Out Involving and Informing Patients Globalisation/ Inspections Innovation in R&D Models and Regulatory/Competitive Lifecycle Approach Ethics: Legal Perspectives Sessions Intelligence
Wednesday, 26 March 2014 Wednesday, 26 March 2014 Wednesday, 26 March 2014
Session 0601 Session 1601 Session 0101/0301 Session 0201 Session 0101/0301 Session 0401 Session 0701 Session 1001 Session 1301 Session 1 Session 0501 The Importance for All to Adopt the New Session 0901 What Can Regulatory Intelligence Making the Pharmacovigilance Creating an Adaptive Pathway for Making the Pharmacovigilance Paediatric Rewards- where do we eTrial Master File (eTMF): Regulatory Harmonisation and Transparency – is clearing the past 09:00-10:30 Translation of Personalised Medicine Concepts Paradigm in Clinical Research: Patients as Partners in Clinical Research Groups Learn from Experts in Legislation Work – a temperature check Medicines to Patients Legislation Work – a temperature check Stand? Clinical in the Clouds? Regulatory Convergance- an update clouding the future? Introductory session Knowledge Management?
Room B Level O2 Room E2 Level OE Room B Level O2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room 6AB Level O1 Session 1602 Session 0102 Session 0202 Session 1002 Session 0302 Session 0702 Session 0902 Session 1302 Session 1402 The Practical Aspects of the Session 2 Hurdles to Overcome to Ensure How do Payers View Current Session 0402 Session 0502 Surviving Safety and Quality Thinking Beyond Old eClinical: Faster, better, high-quality trial Patient Empowerment: Opportunities Disclosure of Clinical Trial Data- Innovation through Public Private Regulatory Intelligence 11:00-12:30 Regulatory Success for the Next Developments in the HTA and Regulatory Latest Developments in Pediatrics From Biomarkers to Companion Diagnostics Inspections in Pharmacovigilance Boundaries set-up and conduct and challenges what does the future hold? Partnership Collaborations Function-Organisation and Generation of Products Environment? the Era of Globalisation Processes Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0603 Session 0203 Session 0403 Session 0503 Session 0703 Session 1303 Session 1403 Session 1603 Session 3 Session 0103 The New Paradigm in Clinical Research: Session 1003 Established Interactions throughout the Developing Medicinal Products for Older Health Economic Aspects of eClinical: From case decision to Early Access to Unauthorised Innovation in Biomarkers and Regulatory Intelligence Input into 14:00-15:30 Regulatory Town Hall Meeting The case for developing new roles, skills Global Development and Supply Registration Pathway People –getting on track Personalised Medicine strategic alignment Medicines Disease Stratification Development Strategies and competencies
Room B Level O2 Room G Level U2 Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0604 Session 1004 Session 1604 Session 0104 Session 0204 Session 0304 Session 0504 Session 0704 Session 0904 Session 1304 Session 1404 Session 1704 Session 4 Optimising Clinical Research: Which GCP Inspections – international Regulatory Intelligence in Practice How to Get Ready for the New Clinical Databases, Registries and other Current Industry Practice for Benefit/ The Societal Perspective on Data Integration: Reaching the next Efficient Use of Social Media to Work Unintended Implications of Innovation in Clinical Trial Design The Case For and Against a Reform 16:00-17:30 infracturial and business relationship changes collaboration and harmonisation - how regulatory authorities inform Trials Legislation Data Capture Tools Risk Governance Personalised Medicine level of efficiency with e-Patients Transparency and Evaluation of the Pharmaceutical Legislation do we need to consider? efforts about decision making
Room E1 Level OE Room G Level U2 Room E2 Level OE Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1 Room H Level U2 Thursday, 27 March 2014 Thursday, 27 March 2014 Thursday, 27 March 2014
Theme 1 Theme 2 Theme 3 Theme 8 Theme 11 Theme 6 Theme 12 Theme 15 Theme 10 Theme 13 Theme 14 eHealth: Innovation in Benefit/Risk Management and Regulation of Medical Devices and Pharmaceutical Quality in the 21st New and Known Active Substances - The Role of Transparency and Hot Topics/Stand Alone Hot Topics/Stand Alone Regulatory Science HTA/Regulatory Interface Healthcare and its Impact on Innovation in Clinical Research Globalisation/ Inspections Innovation in R&D Models Lifecycle Approach Combination Products Century how to fit the rules to needs Ethics: Legal Perspectives Sessions Sessions Industry
Session 0105 Session 1005 Session 1705 Session 0305 Session 0805 Session 0605 Session 1205 Session 1505 Session 1305 Session 1405 Session 5 Biosimilars- building in European Session 0205 Global Submission and Review The Changing Face of the EMA Transparency in the Pharmaceutical European Commission’s eHealth Innovative Methodologies Used Quality by Design (QbD) and Innovation in New Active Substances and Known Active Transparency of Payments to the Innovation in Drug Delivery Systems 09:00-10:30 foundations to achieve Global Marketing Authorisation and Beyond Strategy - how rapidly innovation Inside and Out: An overview of the Sector – what have we learned? Action Plan 2012-2020 in Enhancing Quality Development and Manufacturing Substances – designation, implications Healthcare Sector and Compliance Harmonisation can reach global markets new structure and expectations
Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room I Level U2 Session 1006 Session 0106 Session 0606 Session 1306 Session 0306 Session 0806 Session 1106 Session 1206 Panel Discussion: Regulation 2025 Session 1406 Session 1706 Session 6 Challenges and Opportunities in Workshop: The New Paradigm in Clinical Session 1506 Diclosure of Safety Data: Can PRAC, Moving from Risk Management to Interoperability for Healthcare The New Regulatory Outlook for Devices, Experience with Implementation of – stakeholder vision for the future Innovation in Preclinical and Japanese Regulatory Session: 11:00-12:30 the Implementation of the Falsified Research: Stakeholder perspectives for a How to Realise Biosimilars’ Full Potential patients and industry perspective be Benefit/Risk Management Planning Providers across the EU IVDs and Combination Products the Lifecycle Approach of the global regulatory framwork Clinical Safety Sciences PMDA Update Medicines Directive rational process reconciled? between now and 2025 Room E1 Level OE Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room G Level U2
Session LB01 Session LB01 12:45-13:45 Briefing on ATMPs
Room 12 Level U2 Session 1707 Session 0207 Session 0307 Session 1007 Session 0107 Session 1107 Session 0607 Session 1507 Session 1307 Session 1407 GCP Hot Topic 1- The Use of Session 7 How Do We Bring the Patient’s Voice Periodic Benefit/Risk Evaluation Session 0807 Current Status and Future Optimising Regulatory Operations Key Considerations for Development and Systematic Approaches to Deliver Quality: How to Overcome the Obstacles in Product Liability, Off-Label Use Non-Clinical Development Strategies Electronic Health Records by 14:00-15:30 into the Discussion? How do we ensure Reporting – Has it achieved what it Big Data, eHealth and Taxonomy Challenges of the Asian Regulatory through Use of Information Technology Approval of Companion Diagnostics Learn from the Experts! Patients’ Access and Patient Information Leaflets for Biosimilar Monoclonal Antibodies Investigators and Sponsors for that all the right voices are heard? set out to do? Environment Clinical Research Room E1 Level OE Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level O1 Room 5AB Level O1 Room LM Level O1 Room F2 Level OE Room NO Level O1 Room 6AB Level O1
Session 0308 Session 0208 Session 1108 Session 0608 Session 1208 Session 1508 Session 1008 Session 8 Risk Minimisation and its Effectiveness – Session 0808 Session 1408 Session 1708 Are Our Healthcare Systems Ready to Clinical Investigations for Medical Devices The Brave New World of Digital Data: What are Challenges and Opportunities for Risk Perception, Risk Management and Known Regulatory Simplification: Vision, 16:00-17:30 what is state of the art and The Role of Social Media in Healthcare Pharma Industry Incentive Systems GCP Hot Topic 2 Support These Approaches? and Combination Products the new ethical and legal questions? Pharmaceutical Quality Active Substances oxymoron, or ‘mission impossible’? what is realistic?
Room G Level U2 Room E2 Level OE Room H Level U2 Room I Level U2 Room F1 Level OE Room K Level U2 Room 5AB Level O1 Room LM Level O1 Room NO Level O1 Room 6AB Level O1 77 about the dia euromeeting about VIENNA
About the DIA EuroMeeting
DIA’s Annual EuroMeeting is global in scope and attracts attendees from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations. This convergence affords participants the opportunity to network with professional colleagues from around the world.
DIA is a global association of approximately 16,000 members who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. DIA is committed to the broad dissemination of information on the development of new medicines or generics, biosimilars, medical devices and combination products with continuously improved professional practice as the goal. DIA is an independent non-profit organisation. The voluntary efforts of DIA members and speakers allow DIA to organise conferences, workshops and training courses and provide educational publications.
About VIENNA
Vienna is the capital and the largest city of Austria, and one of the nine states of Austria. Vienna is Austria's primary city, with a population of about 1.7 million and is by far the largest city in Austria, as well as its cultural, economic, and political centre. It is the 9th-largest city by population in the European Union. Until the beginning of the 20th century it was the largest German-speaking city in the world. Vienna is host to many major international organisations, including the United Nations and OPEC. The city lies in the east of Austria and is close to the borders of the Czech Republic, Slovakia, and Hungary. These regions work together in a European Centrope border region. Along with nearby Bratislava, Vienna forms a metropolitan region with 3 million inhabitants. In 2001, the city centre was designated a UNESCO World Heritage Site.
Apart from being regarded as "The City of Music", because of its musical legacy, Vienna is also said to be "The City of Dreams" because it was home to the world's first psycho-analyst - Sigmund Freud. The city's roots lie in early Celtic and Roman settlements that transformed into a Medieval and Baroque city, the capital of the Austro-Hungarian Empire. It is well known for playing an essential role as a leading European Music Centre, from the great age of Viennese Classicism through the early part of the 20th century. The Historic centre of Vienna is rich in architectural ensembles, including Baroque castles and gardens, as well as the late- 19th-century Ringstrasse lined with grand buildings, monuments and parks.
In a 2005 study of 127 world cities, the Economist Intelligence Unit ranked the city first (in a tie with Vancouver, Canada) for the world's most livable cities (in the 2012 survey of 140 cities Vienna was ranked number two, behind Melbourne).
The city was ranked first globally for its culture of innovation in 2007 and 2008, and fifth globally (out of 256 cities) in the 2011 Innovation Cities Index, which analysed 162 indicators in covering three areas: culture, infrastructure and markets. Vienna regularly hosts urban planning conferences and is often used as a case study by urban planners.
Each year since 2005, Vienna has been the world's number one destination for international congresses and conventions. Vienna attracts about five million tourists a year.
More information on Vienna can be found at: http://www.vienna.convention.at or visit the Vienna Convention Bureau booth 516 in the exhibition hall Y.