Monaco 2010 PRELIMINARY PROGRAMME

Annual22nd

EUROMEETING Monaco 2010 PRELIMINARY PROGRAMME

March 8-10, 2010 Grimaldi Forum Monaco 22nd DIA Annual EuroMeeting Programme Committee

Theme Leaders

Christelle Anquez-Traxler Jackie Hunter Marisa Papaluca Amati Regulatory and Scientific Affairs Senior Vice President, Science Deputy Head of Sector, Safety and Manager, AESGP, Belgium Environment Development, Efficacy of Medicines, EMEA, EU GlaxoSmithKline, UK

Valdo Arnera Brenton James Tomas Salmonson General Manager, Europe, PHT Consultant in Strategic Regulatory Vice Chair CHMP, MPA, Sweden Corporation, Switzerland Affairs in the European Union, UK

Mary Baker Angelika Joos Gabriele Schwarz President, European Federation of Director, Regulatory Policy Europe, Head, GCP Inspection Services, BfArM, Neurological Associations, UK Merck Sharp & Dohme (Europe) Inc., Germany Belgium

Patrick Celis Craig Johnson Thomas Severin Scientific Administrator, EMEA, EU Principal Regulatory Scientist, Head Paediatrics, Novartis Pharma AG, Regulatory Information & External Switzerland Affairs, Eli Lilly, UK

Catarina Edfjäll Thomas Kühler Nick Sykes Head of Regulatory Affairs Europe, Director of Operations, MPA, Sweden Director, Head, Global Regulatory Celgene International SARL, Switzerland Intelligence and TA Analysis, Pfizer, UK

Zaide Frias Pierre-Yves Lastic Geoff Tucker Scientific Administrator, Senior Director, Data Privacy & Emeritus Professor of Clinical Legal/Regulatory Affairs, EMEA, EU Healthcare Interoperability Standards, Pharmacology, University of Sheffield, sanofi-aventis, France and Chairman of Simcyp Ltd., UK

Trevor Gibbs Hubert Leufkens Beat Widler Executive Vice President, ii4sm, Professor, Division of Global Head, Clinical Quality Assurance, Switzerland Pharmacoepidemiology and F. Hoffmann-La Roche AG, Switzerland Pharmacotherapy, Utrecht Institute for Pharmaceutical Studies, The Netherlands

Wills Hughes-Wilson Damian O’Connell Senior Director, Health Policy Europe, Executive Director, Clinical R&D, Pfizer Genzyme, Belgium Ltd., UK

About the DIA EuroMeeting

The Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic research centres, regulatory agencies and health ministries. This convergence affords attendees the opportunity to network with professional colleagues from around the world.

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. We are committed to the broad dissemination of information on the development of new medicines or generics and biosimilars, with continuously improved professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itself from meeting and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications at a reasonable, competitive cost.

Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior Event Manager (EuroMeeting): [email protected] or call +41 61 225 5132

Bruno Flamion Professor, Clinical Pharmacology, University of Namur, Belgium Dear Colleague, and Chair, CHMP, Scientific Advice Working Party, EMEA

Bruno Flamion is an MD who practised internal medicine and nephrology in It is our pleasure to invite you to participate in three days of discussion, sharing of experience, moving the debate forward and networking at Belgium. He was a Research Fellow at the NIH (1988-1992) and with the the 22nd Annual EuroMeeting in Monaco, March 8-10, 2010. Whether Belgian National Fund for Scientific Research (1992-1996) and later got a PhD your involvement will be as a session chair, speaker, tutorial instructor, in physiological sciences from the University of Brussels. He is now Full or attendee, and whether you are a representative of a regulatory Professor of Physiology and Pharmacology at the University of Namur, agency, from academia, industry or a patient group, or a student or Belgium, where he heads a molecular physiology lab. He has been involved as young professional, we believe you can play a key role in building the a medical expert for the Belgian Federal Agency for Medicines and Health success of the EuroMeeting and ensuring its place as one of the most Products (FAMHP) since 1999 and for the EMEA: CHMP, PK group, important European conferences for professionals involved in the Pharmacogenomics, and more recently CAT (Committee for Advanced development of medicines. Therapies). His favourite activity is chairing the Scientific Advice Working Party.

When deciding on the themes, we have chosen the integrated, multi-disciplinary approach, aiming to generate interest from as many disciplines as possible. We hope we have identified interesting and thought-provoking topics for the themes. With this approach we wish to create a lively platform for a debate on development and market access of medicines in Europe.

Being aware that many of you will be keen to look for your specific area of interest in the programme, as the programme is developed we will Kerstin Franzén highlight clearly on the EuroMeeting website and in the advance Senior Director, Regulatory Policy & Intelligence, programme which sessions will discuss, for example, non-clinical aspects, Pfizer, Sweden statistics, etc. Kerstin Franzén has a background in Regulatory Affairs covering 29 years. Monaco is an exciting location, well-known to most people. Despite After an academic degree at Uppsala University, M Pharm Sci, she joined the being a small country, it has a lot to offer and is very hospitable and pharmaceutical industry, first for a short period in the marketing area, and culturally interesting. No doubt there are numerous challenges around then went into the regulatory arena. The first seven years were spent with the but we strongly believe you should not miss this opportunity to bring Roche affiliate in Sweden, followed by a move to the Swiss headquarters your contribution to the debate on drug development. Make your plans to come to Monaco next year! where she stayed for four years, still in Regulatory Affairs. In 1990 she decided to join Kabi Pharmacia and go back to Sweden. This company went through Bruno Flamion and Kerstin Franzén a number of mergers and acquisitions, which eventually led to her current position with Pfizer in Regulatory Policy & Intelligence, an area she has been Programme Advisors involved in since 1998.

Daniel Brasseur José Ramet EMEA PDCO, Federal Agency for Medicines and Professor, University of Antwerp, Chairman, Medicinal Products, Belgium Paediatric Department, University Hospital Antwerp and Queen Paola Children’s Hospital, Emmanuel Chantelot Belgium Executive Manager, European Biopharmaceutical Enterprises, Belgium Malcolm Rowland Susie Stephens Emeritus Professor, School of Pharmacy and Principal Research Scientist, Eli Lilly and Company, Daan Crommelin Pharmaceutical Sciences University of USA Scientific Director, Top Institute Pharma, Manchester, England The Netherlands Wolfgang Summa Agnès Saint Raymond Executive Vice President, Business Development, Hans-Georg Eichler Head of Sector, Scientific Advice, Paediatrics and OmniComm Systems, Germany Senior Medical Officer, EMEA, EU Orphan Drugs, EMEA, EU Erik Tambuyzer Julianne Hull Christian Schneider Senior Vice President, Corporate Affairs, Europe Senior Director, Global Development Data Acting Head, Division EU Cooperation/ and International, Genzyme, Belgium Operations, Wyeth Research, UK Microbiology, Paul-Ehrlich-Institut, Germany, and Chair, CHMP, Biosimilars Working Party Catherine Tuleu Tim Kievits Senior Lecturer and Deputy Director, The School CEO, PamGene, Chair of EuropaBio Personalised Beatriz Silva Lima of Pharmacy, University of London, UK Medicines Working Group, The Netherlands CHMP and SAWP Member, SWP Chair; Professor, Pharmacology, University of Lisbon, INFARMED, Portugal 3 2010 Themes and Theme Leaders

Theme 1 will be the topic of another session. Misuse of medicines and counterfeiting are Innovation other facets of globalisation and closely linked to the widespread use of the Jackie Hunter, Senior Vice President, Science Environment Development, internet. A session will review the so far rather neglected topic of misuse of GlaxoSmithKline, UK therapeutic agents in doping. Doping would not be made so easy without Damian O’Connell, Executive Director, Clinical R&D, Pfizer Ltd., UK manufacturing capacities in countries with weaker regulatory controls and e- commerce, and this leads to another session about counterfeiting. New Theme Overview regulations and mounting pressure are also an opportunity for smarter strategies New medicines development is going to require innovation at all stages of the and the use of “intel-ligence” for study management and quality oversight: drug discovery and development process. The challenges that companies face progress of the CTTI imitative, innovative approaches to quality risk in bringing medicines to the market, in ways that are both time and cost management that makes extensive use of computerised processes, and in the effective, are huge. These challenges are driving new ways of working both management of partners will be the focus of three sessions. within companies, between companies and between academia and industry. The Innovative Medicines Initiative is a public/private partnership that will drive Proposed Sessions pre-competitive data sharing and new ways of working between industry and 1. Transparency: A Pandora’s box or a panacea? academia. Open innovation has produced demonstrable benefits for other 2. The price of globalisation: Is industry indeed exploiting Indian patients? industries – could it do the same for pharma? The theme will examine where What should we all know about Indian society, medical practice and the boundaries might lie for both pre-competitive data sharing and open patients? innovation. New clinical designs and methodologies are being employed both 3. The price of globalisation: The costs, benefits, risks and pitfalls when for clinical trials and experimental medicine studies and some of these moving development and manufacturing to Latin America approaches will be discussed. Finally some examples of innovation in 4. Counterfeiting: Who owns the problem? Who is in control? translational medicine and preclinical studies will be described. 5. Misuse of medicines and doping: What is the problem? How big is the problem? Proposed Sessions 6. Quality Risk Management: Myth, promise or a solution to the 1. The Innovative Medicines Initiative operational challenges of clinical development and regulatory 2. Is an open innovation paradigm the way forward for pharma? compliance 3. The importance of pre-competitive data sharing to accelerate drug 7. CTTI (Clinical Trial Transformation Initiative): What has been achieved? development Has it already delivered on the expectations raised? 4. What is an innovative medicine? 8. Governance challenges when managing partners such as CROs and 5. Innovation in early and late phase clinical trials I licensing partners 6. Innovation in early and late phase clinical trials II 9. Managing the end of lifecycle of a medicinal product 7. Have the benefits of translational medicine been realised? 8. Innovative preclinical research underpinning drug discovery and development Theme 3 Paediatric Medicines – Did the Regulation Deliver on its Promises? Theme 2 Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp & Dohme Staying in Business: How to Make Sure you Comply With (Europe) Inc., Belgium All Rules and Regulations Thomas Severin, Head Paediatrics, Novartis Pharma AG, Switzerland Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffmann-La Roche AG, Switzerland Theme Overview Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany This theme will reflect on the opportunities and current challenges of paediatric drug development. The new paediatric legislation was established in Europe Theme Overview over three years ago and some early stocktaking can already be made: The In the EU, the Pharmaceutical Package and in other countries other new rules impact of the new framework is multi-dimensional and touches on many and regulations have created new obligations. Also advocacy groups, the public aspects of new product development and lifecycle management. Regulators and and the media – the scientific as well as the general press – are also becoming Industry are discussing the adequate implementation of the new requirements more active and demanding. This makes the development of new medicines and are negotiating Paediatric Investigation Plans. The overall goal is to meet the more and more demanding, not only from a clinical and scientific perspective needs of children in many therapeutic areas whilst delivering the best possible but also from a process and regulatory aspect. safety protection for the population. Researchers and Industry are collaborating to set up the necessary infrastructure to conduct numerous paediatric studies Globalisation is, for instance, seen by some as progress as patients in developing within a global R&D scope. They define new uniform standards as well as clinical countries are getting access to innovative medicines through earlier involvement and non-clinical methodologies to overcome the various challenges in the in clinical trials and because of a strengthening of local economies through unique paediatric environment. Better and more innovative paediatric improved healthcare systems. Others are fearful that there is a shift in the focus formulations are needed to address the selective preferences of children and of clinical development from industrialised countries to Asia and Latin America enable good compliance with a treatment for optimal outcomes. Involvement of and thus depriving investigators in these “traditional” regions of access to patent attorneys and lawyers is recommended for the development of a strategy clinical trials, and that trials in developing countries are a new form of to claim and achieve the deserved benefits in compensation for undertaking the colonialism and results in the exploitation of vulnerable populations. The additional research investments. A preliminary assessment of the positive impact counterargument to this is a not uncommon topic in the debate about on public health in balance with required resources will be made. development: protection of patients in developing countries by well-intentioned and often self-nominated advocates from the so-called industrialised countries Proposed Sessions is nothing else than paternalism. Two sessions will look at this conflict and give 1. Regulatory challenges and experience with new paediatric requirements background information about patients, the healthcare system and risks and 2. Focusing on pharmacovigilance and safety aspects of paediatric trials benefits when conducting clinical trials in India and Latin America. In this context 3. Design and conduct of ethical paediatric clinical programs the expectations of the public for transparency do not come as a surprise and 4. Paediatric Development - Is a global strategy achievable?

4 2010 Themes and Theme Leaders

5. Paediatric formulations: Will they reach the market? Theme Overview 6. Harmonised regulatory expectations for juvenile animal testing? From recombinant therapeutic proteins and monoclonal antibodies, to advanced 7. Challenges for obtaining the rewards therapies like cell-based and gene therapy medicinal products, each new 8. Initial impact of the Paediatric Regulation after three years generation of biotechnology-derived medicines comes with great opportunities and interesting challenges. In Europe, the Advanced Therapies (ATMP) legislation was implemented in December 2008 and it has brought a new Theme 4 Committee for Advanced Therapies (CAT) and novel regulatory procedures for Decision Making - The Key to Efficient and Effective advanced therapies to the EMEA. Additionally, biosimilars have been evaluated Drug Development, Approval and Access and regulated in Europe for a few years now, as several biosimilar recombinant Craig Johnson, Principal Regulatory Scientist, Regulatory Information & therapeutic proteins have been approved and are being commercialised in External Affairs, Eli Lilly, UK Europe. Tomas Salmonson, Vice Chair CHMP, MPA, Sweden This theme will address the opportunities and challenges raised by today’s Theme Overview innovative breakthroughs using new biotechnology platforms and novel Effective “decision making” is essential for innovative medicinal products to be treatment approaches. It will specifically discuss how the evolving regulatory made available to patients. During the last decade, new stakeholders have environment impacts on companies working in this cutting-edge research area emerged who are influencing which product may finally be taken by an and on regulators performing the assessment of such products, which individual patient. Company strategies, regulatory approvals, assessments by sometimes come with highly specific requirements. The experience in the first HTA bodies, international and national treatment recommendations, local drug year of the ATMP legislation and the CAT will be reported, as we get closer to committees, opinion leaders, treating physicians and, in the end, the (informed) seeing new advanced therapies available to patients. Specific case studies and patient may influence choice of treatment. Decision making by all these examples will be shared. Borderline areas in the legislation around medical stakeholders is complex and subjective by nature. Regulatory bodies strive to devices and combination products will also be examined. make their assessment of the benefit/risk of a new product a valuable tool for other parties, not least of which are the increasingly prominent HTA bodies. Biotechnology-derived medicines have opened and will continue to open up However, this aim, while laudable from an efficiency point of view, can only be huge treatment opportunities for patients, and we need to understand if the fully achieved by building trust through adequate and appropriate transparency. complexity of new generation medicinal products could impact the Hence, there needs to be a description of the decision making clear enough to responsibilities of healthcare professionals and requirements for risk allow the reader to agree or disagree with the decision, and to understand the management plans. applicability of that decision in the context of their own decision making. Proposed Sessions Correspondingly, this increasingly complex environment demands that 1. CAT Experience in the first year pharmaceutical companies make critical decisions on the most efficient and 2. ATMP borderlines effective drug development programme to meet both regulatory and HTA 3. ATMPs and biotherapeutics – Do they require changes to established needs. The aims of this theme are to examine these elements and consider the quality and manufacturing concepts? ways in which decision-making processes may need to change in response. 4. Impact of new therapies on preclinical research Ways to approach benefit/risk decisions and increased transparency in this 5. Clinical research: New therapies - new challenges process will be discussed both from an industry and regulatory/healthcare 6. Biosimilars-Areality check provider aspect. Various specific aspects of pre- and post-approval decisions will 7. Advanced therapies and medical devices - Living with a new risk be debated. management reality? 8. Health Technology Assessments - Are they possible for advanced therapies? Proposed Sessions 1. Patient influence on regulatory decisions: How much do they and should they have? Theme 6 2. Should regulatory processes become more transparent and, if so, how? Challenges for Switching Centrally Authorised Products 3. Conditional approvals: How to strike the right balance between early from Prescription to Non-Prescription Status access, patient safety and commercial reality? Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, 4. Clinical trials: The demise of traditional surrogate markers? How to create Belgium new markers? Zaide Frias, Scientific Administrator, Legal/Regulatory Affairs, EMEA, EU 5. The true value of risk management for decision making and for post- approval commitments Theme Overview 6. Evolving the benefit/risk concept and the use of quantitative models: With Regulation (EC) No. 726/2004, the centralised procedure became a new Where are we now and where are we going? route for the change of legal status of medicines hence allowing their access as 7. Influence of HTA on regulatory decision making: Reality? An opportunity? a non-prescription medicine across the EU at once. This is breaking new grounds A threat? for industry, the EMEA and national authorities and generating new 8. Company decision making during drug development opportunities but also challenges and question marks. Taking the views of regulators, industry, healthcare professionals and patients/consumers, this theme will reflect on both the experience accumulated so far and on future Theme 5 trends. The impact on national markets and national attitudes will also be an Paving the Way for Advanced Therapies - Fostering New important and interesting question for debate. Ensuring that the Generations of Biotechnology-Derived Medicines patients/consumers get the right level of information is paramount in the self- Catarina Edfjäll, Head of Regulatory Affairs Europe, Celgene International care context and this may bring new questions and challenges when discussed SARL, Switzerland at EU level. Last, will the centralised procedure give a new chance to well- Patrick Celis, Scientific Administrator, EMEA, EU established molecules and/or its combinations? Ultimately, will the centralised procedure, coupled with incentives and better regulation principles, contribute to boost the competitiveness of the European self-care sector?

5 2010 Themes and Theme Leaders

Proposed Sessions Theme 8 1. ‘Central switches’ - Where are we going? Taking the European Regulatory Infrastructure Forward 2. Switching trends: Evolution or revolution? Brenton James, Consultant in Strategic Regulatory Affairs in the European 3. Could the UK model be reproduced at EU level? Union, UK 4. Impact of EU decision on non-prescription status at the national level Thomas Kühler, Director of Operations, MPA, Sweden 5. Information to patients/consumers: Fit for purpose? 6. New chance for well-known substances: CP vs. MRP/DCP Theme Overview 7. Are the incentives provided in the legislation sufficient to boost innovation This theme will address many issues concerning the procedure of gaining at EU level? regulatory approval and market access for medicinal products in Europe. The 8. Is a Risk Management Plan supportive of innovative switches? European Commission has set out both a communication and several legislative proposals on patient information, counterfeit medicines and pharmacovigilance. This is draft legislation that will go via the co-decision procedure through the Theme 7 Council and the European Parliament. The European Medicines Agency is Personalised Medicine changing to be able to handle the additional responsibilities of Advanced Wills Hughes-Wilson, Senior Director, Health Policy Europe, Therapies and the changing nature of the types of marketing applications that Genzyme, Belgium are being filed in the Centralised Procedure. As the CHMP plays a pivotal role Marisa Papaluca Amati, Deputy Head of Sector, Safety and Efficacy of at the European Medicines Agency, its role and objectives will be described and Medicines, EMEA, EU a survey of all applications in 2008 will provide key learning points for the development of medicinal products. The European Medicines Agency sets out Theme Overview its strategic vision in the publication of Roadmaps.. The success of the Roadmap Personalised Medicines is an increasingly “hot topic” – but whether it is seen as up to 2010 and the map for the next five years will give an understanding of the a threat, an opportunity or the very essence of the future (bio)pharmaceutical direction the Agency will follow. As a complement to the Agency's Roadmaps, industry depends largely on who you are talking to. This theme will outline what the Heads of Agencies released their Strategy Paper setting out the ambition for personalised medicine and targeted therapies mean in reality and will explore National Competent Authorities in the future. Stakeholders are interested in the how the field can be developed to its full potential. Several regulatory agencies resources that are available to support the Decentralised and Mutual have taken steps to address the emerging possibilities to target therapies either Recognition Procedure and how they will be allocated. Industry sees much to during or after development, to reduce side-effects and increase effectiveness. gain in a dialogue with regulators. Ways that dialogue may be enhanced to the Where we go from here and what happens next will largely determine if this benefit of both industry and Agencies will be explored so that creative field develops or remains a complicated niche. This theme will build on suggestions can be offered for further discussion. Recognising that the approval experience to date, learning from the existing diagnostic and therapy of a marketing application is the first step to the availability to patients of a relationships. It will examine regulators’ points of view from different medicine, the vital role and contribution of Health Technology Assessment geographic locations and explore the attitudes of other stakeholders in the bodies will be presented so that the interaction between the two organisations healthcare field, be they patients, industry, payers or physicians. It will explore can be understood by stakeholders. Europe is one of the three major what steps need to be taken to achieve a successful marketing authorisation for pharmaceutical markets in the world and co-operation between regulatory a diagnostic-and-drug combination and what needs to be done to support and agencies in these countries and others are important for public health. encourage the fields that will be crucial to the success or otherwise of this field, including diagnostics and IT systems. And finally, participants will discuss how Proposed Sessions we will handle the data that is gathered, what intellectual property and privacy 1. The Pharmaceutical Package - The latest information issues might be created and how can we address them? Representatives from 2. The European Medicines Agency and its committees all aspects of the growing and inter-disciplinary personalised medicines field will 3. CHMP: Its role and objective for 2010 participate in this theme, with the objective of advancing the debate and 4. The European Medicines Agency and the Roadmaps bringing clarity in where we stand and where we need to go from here. 5. Achievements of the Heads of Agencies 6. Industry and regulators dialogue Proposed Sessions 7. Agencies and health technology assessment bodies 1. Personalised medicines: What is it, where do we stand and where are we 8. International co-operation with regulatory agencies going? 2. One medicine does not fit all. And one business model does not fit all. Which business models have worked and what can we learn? Theme 9 3. Is Europe adapted to personalised medicines? What needs to change? Risk Management 4. DNA Sampling - A logistical and organisational challenge or impossible Trevor Gibbs, Executive Vice President, ii4sm, Switzerland hurdle? 5. Evidence and study designs in Personalised Medicines Theme Overview 6. Evidence and study designs in Personalised Medicines in a post-authorisation Risk management remains a topic on everyone’s agenda. We will reflect on the setting implementation of regulations by the EMEA and FDA over the last few years, 7. International regulatory frameworks in the field of personalised medicine – describe some of the major research initiatives in the area and provide practical converging or diverging? working examples from industry and regulators. Above all, the theme will reflect 8. Diagnostics - If this is such a crucial element of the whole field, what are the multi-disciplinary approach that is required to create a clear picture of what we doing to support, encourage and protect the diagnostics field? we know, what we don’t know and how to address harm minimisation and benefit maximisation for patients and customers.

Proposed Sessions 1. Regulatory developments in risk management in the EU and US 2. Special requirements for the safety of biologicals 3. Performance, quality control and audit in pharmacovigilance and risk management

6 2010 Themes and Theme Leaders

4. Non-clinical support to aid risk management Proposed Sessions 5. Risk management - but what about the benefit? 1. The new IT Architecture for meeting the challenges of eHealth 6. Observational and clinical data sets? Weight of evidence 2. ePRO Use and Validation 7. Risk management for switch products 3. EDC Case Studies 8. Research initiatives in risk management 4. Emerging technologies for optimisation of patient treatment 5. Improving drug safety through the use of new technologies 6. Healthcare interoperability standards Theme 10 7. Utilisation of electronic medical records in clinical development The Informed Patient 8. Connecting healthcare and clinical research Nick Sykes, Director, Head, Global Regulatory Intelligence and TA Analysis, Pfizer, UK Mary Baker, President, European Federation of Neurological Theme 12 Associations, UK Pharmaceutical Sciences in 2020 Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University of Theme Overview Sheffield, and Chairman of Simcyp Ltd., UK An overview and discussion on the use and provision of information on Hubert Leufkens, Professor, Division of Pharmacoepidemiology and medicinal products to and by patients covering the following areas: Pharmacotherapy, Utrecht Institute for Pharmaceutical Studies, The Netherlands • The use of information by patients: Will having more information enable patients to provide an increasingly meaningful contribution to the Theme Overview management of their healthcare? What contribution to healthcare systems can The pharmaceutical sciences are likely to look very different in 10 years time. knowledgeable patients make? These sessions will peer into the crystal ball with respect to changes in research • An exploration of the information on medicines that is available to patients emphasis, enabling technology, paradigms for drug development, evaluation and information that is wanted by patients focussing on: the impact on and regulation and the education of the workforce. patients with the availability (or lack thereof) of information on medicinal Proposed Sessions products; an analysis of what information patients would like and in what form 1. What major research activities will drive drug discovery and development? vs. the information 'holders'/producers are willing to give against the backdrop 2. What will the enabling technologies be? of what information can legally be provided to patients; can patients fully 3. What paradigm/geographical shifts will there be in drug understand the information currently available to meet their healthcare needs? discovery/development? • A discussion on whether all access points for information are utilised to the 4. How will regulators reconcile the need for rapid market access with the best effect: the internet is not the nirvana – ‘traditional’ methods for providing assessment of benefit/risk? information are still important; the pros and cons of centralised access points 5. How will changes in education meet the demands of industry and and greatly dispersed access points; how can all stakeholders ensure consistent regulation? communication across states, languages and cultures to facilitate a common understanding Confirmed Session Chairs

Proposed Sessions John Balian, Vice President, Worldwide Janis Little, Senior Director, Development Head Clinical Safety & Risk Management, Quality & Compliance, Genentech Inc., 1. The Pharmaceutical Package: Information to patients proposals – what Pfizer Inc., USA USA difference will they make? Lyle Bootman, Dean & Professor, Carolin Miltenburger, Director HEOR, i3 2. Communication of information on medicinal products (1) – how can a University of Arizona, USA Innovus, Germany balance be achieved between legal restrictions and patient expectations? Olivier Rabin Matthias Bündte, Principal, Booz Allen Science Director, WADA, Canada 3. Communication of information on medicinal products (2) – factors to Hamilton AG, Switzerland consider to ensure optimum accessibility and understanding Andrew Rut, Vice President, Global Emmanuel Chantelot, Executive 4. Patient use of information on medicinal products Clinical Safety and Pharmacovigilance, Manager, European Biopharmaceutical GlaxoSmithKline, UK 5. What information do patients want on medicinal products and how far do Enterprises, Belgium Christian Schneider, Acting Head, the current provisions go to meet these needs? Hubertus Cranz, Director-General, Division EU Cooperation/Microbiology, 6. How involved can informed patients be in the development and AESGP, Belgium Paul-Ehrlich-Institut, Germany, and Chair, CHMP, Biosimilars Working Party commercialisation of medicines ? Daan Crommelin, Scientific Director, Top 7. Patient involvement in regulatory decision making Institute Pharma, The Netherlands Beatriz Silva Lima, CHMP and SAWP Member, SWP Chair; Professor, 8. Are informed patients cost-effective? How to ensure that patients Shirish Dattatraya Sherlekar, Practice Pharmacology, University of Lisbon, understand the decisions being made on their medicines Head, Life Sciences, Tata Consultancy INFARMED, Portugal Services, Ltd, India Burkhard Sträter, Lawyer, Kanzlei Sträter, Sergio Guerrero, Director,OCA Germany Theme 11 Hospital/Monterrey Intl Research Center, Wolfgang Summa, Executive Vice Mexico eHealth President, Business Development, Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland Julianne Hull, Senior Director, Global OmniComm Systems, Germany Development Data Operations, Wyeth Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Panos Tsintis, Medical Director, Choice Research, UK Standards, sanofi-aventis, France Pharma, UK Pierre-Yves Lastic, Senior Director, Data Geoff Tucker, Emeritus Professor of Theme Overview Privacy & Healthcare Interoperability Clinical Pharmacology, University of Standards, sanofi-aventis, France The influence of technology on Healthcare and Clinical Development has seen Sheffield and UK Chairman, Simcyp Ltd., UK an unprecedented growth in the recent years. The theme intends to cover the Alex Leugger, DRA Manager, F. Hoffmann-La Roche AG, Switzerland contribution these technologies have made and will continue to make; whether John Weiler, President, Compleware Corporation, USA they have been used for a while, like EDC or ePRO, or are still emerging, like Hubert Leufkens, Professor Division of Pharmacoepidemiology & tools to improve drug safety. We will also consider technologies that will shape Phil Wilcox, Vice President, Worldwide Pharmacotherapy, Utrecht Institute for Non-Clinical Safety Projects, the way drugs will be developed and patients will be treated in the future. Pharmaceutical Studies, The Netherlands GlaxoSmithKline, UK

7 Student and Professional Posters

Call for Student Call for Student Poster Abstracts: Full-time university students, residents and fellows are invited to submit abstracts Poster Abstracts: for the Student Poster Session which will take place on Tuesday, March 9, 2010 at the EuroMeeting in Monaco. Deadline: A total of EUR 1,800 in prize money will be awarded to student winners based on Friday, November 6, 2009 the following criteria: • Bona fide research project • Specific objectives and hypothesis • Clear methods • Analysis of actual data and results • Conclusion

A maximum of 20 abstracts will be selected for the student poster presentation.

Eligibility: Full-time students, residents or fellows at the time of the presentation. One author or the author’s designee must attend the EuroMeeting.

Benefits: • One fully supported registration for the EuroMeeting to include: return flight to Monaco, three nights hotel accommodation and complimentary registration for the EuroMeeting • A second complimentary EuroMeeting registration for an accompanying person • Accepted abstracts will be printed in an early 2010 issue of the Drug Information Journal • A total of EUR 1,800 in prize money

Abstracts: • All poster abstracts must be received by Friday, November 6, 2009. Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon. • Abstracts are limited to 100 words • A student may submit only one abstract • Abstracts may not refer to specific brand names • Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions • Submissions must include complete contact information • Abstracts will be reviewed and authors notified of results by Friday, December 11, 2009

Call for Professional Poster Abstracts: A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations to be held on Tuesday, March 9, 2010. Selected professional poster presenters will be required to pay the applicable meeting registration fee and will be responsible for all other meeting expenses.

Abstracts: • All poster abstracts must be received by Friday, November 6, 2009. Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon. • Abstracts are limited to 100 words • Abstracts may not refer to specific brand names • Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions • Submissions must include complete contact information • Abstracts will be reviewed and authors notified of results by Friday, December 11, 2009 Call for Professional If you require further information about Student or Professional Posters, please contact Maureen McGahan at DIA Europe: Poster Abstracts: [email protected] Deadline: Friday, November 6, 2009

8 DIA Fellowships Networking Events

Would you like to receive complimentary admission to the 22nd Annual EuroMeeting in Monaco, March 8-10, 2010, featuring approximately 120 sessions, 350 speakers DIA EuroMeeting and numerous networking opportunities? DIA Young Professional Fellowship: Application Deadline Friday, November 6, 2009 Fellowships 2010 DIA Europe welcomes the involvement of young professionals in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 young professionals in full- time employment under the age of 30.

DIA Student Fellowship: Application Deadline Friday, November 6, 2009 DIA Europe welcomes the involvement of students in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 students in full-time education.

DIA Patient Fellowship: Application Deadline Friday, November 6, 2009 The DIA Patient Fellowship, now in its fifth successful year, is a programme to promote the participation of patients’ organisation representatives in the EuroMeeting. In 2009 DIA supported 22 patient representatives’ participation in the EuroMeeting by covering their complete travel and accommodation costs plus complimentary admission to the EuroMeeting and offered 20 additional patients representative’s complimentary registration for the EuroMeeting, thus enabling a total of 42 patient representatives to participate in the EuroMeeting.

• Complimentary admission to conference • Specific DIA Patient Fellowship Booth to act as a focus point to network and to distribute information • Travel costs covered • Complimentary hotel accommodation provided • Targetted networking opportunities

Fellowship Application Process: To download an application form, please go to www.diahome.org and click on the EuroMeeting icon. If you have any questions, please contact Maureen McGahan at DIA Europe: [email protected]

Networking Events All Included in your Registration Rate!

Networking Receptions, Coffee and Lunch Breaks EuroMeeting 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: food, beer, wine, non-alcoholic beverages and entertainment.

Monday Mediterranean Reception Join us at the Fairmont Hotel on Monday evening for a networking banquet reception. Located in the heart of the Principality of Monaco between the Mediterranean Sea and the legendary Casino of Monte Carlo, it will provide the perfect opportunity to network with other conference participants in a relaxing environment with a backdrop of views of the Mediterranean Sea.

Other Networking Opportunities: • On Tuesday, all attendees get together for a drinks reception on the Exhibition Floor at the Grimaldi Forum Convention Centre. • Speed Networking Sessions • Knowledge Cafés • DIA’s Special Interest Area Communities (SIACs) Networking Lunch. SIACs offer a discipline-specific global community where members can share experiences and knowledge, find common ground, and network with others in their fields. SIAC activities are an integral part of the EuroMeeting. • The EuroMeeting’s Exhibition Floor, with over 200 exhibitors, is a great place to network. All refreshment breaks take place on the Exhibition Floor, so it is easy to meet colleagues and friends. • Patient Representatives are supported each year by DIA to attend the EuroMeeting where attendees will have a chance to meet them and listen to their priorities and concerns. • New to the pharmaceutical industry? The EuroMeeting offers young professionals a specific networking programme which includes a special session, a guidance programme with experienced professionals and a networking reception.

9 Join us in Monaco: Welcome to the EuroMeeting 2010 Global Village

Exhibit at the The Principality of Monaco may be one of the smallest countries in the world but it has an incredible amount to offer. Accessible, glamourous, and with DIA’s specially negotiated hotel rates, very EuroMeeting 2010 affordable, Monaco is one of the world’s most attractive destinations. For three days in March 2010, Monaco’s 33,000 Showcase your company’s inhabitants will be joined by 3,000 EuroMeeting participants. As all hotels are within walking distance of the Convention Centre, product or service to over the 2010 EuroMeeting will have an intimate feel that maximises 3,000 drug development networking opportunities. With picturesque places to discover, professionals at the sites to visit, museums, leisure facilities, shops and boutiques, EuroMeeting 2010 in Monaco. and over 150 restaurants, you may be very tempted to extend your trip.

Join over 200 exhibitors to interact with professionals from the An international hub, easily accessible by air, road and rail, the pharmaceutical, biotechnology, devices, government, academia, Nice-Côte d’Azur International Airport is a 30-minute drive away, healthcare delivery and related industries, from over 50 providing flights to more than 80 destinations throughout the world, and the new TGV railway centre is completely underground countries. and links the town centre to the whole European rail network.

For further information, please contact Phyllis Suter at the Drug Quick facts: Information Association in Europe: Area: Approximately 2 square km (1 square mile) [email protected] or call +41 61 225 5154 Location: Between the French and Italian Rivieras Climate: Sunny weather all-year round Languages: The official language of Monaco is French but English, Italian, as well as Monégasque (local language) are also spoken. Currency: the Euro Government: Constitutional monarchy. The Grimaldi family has ruled over Monaco since 1297.

Discovering Monaco

La Condamine is the port area. Monte Carlo is the main centre for business and entertainment where the famous Monte Carlo Casino is located. Monaco-Ville, the old city built on a rocky promontory extending into the Mediterranean, known as the Rock of Monaco, or simply Le Rocher (the Rock) is where the palace is located. For more information, please go to www.visitmonaco.com

The Convention Centre

The EuroMeeting will take place at the state-of-the-art Grimaldi Forum on the waterfront. This daylight-filled building with its stunning glass entrance is built on land reclaimed from the sea. It opened for conferences in September 2000.

Getting to Monaco By road The European motorway network which passes only 8km from the centre of town links the Principality to France, Spain, Italy, Switzerland, Germany, the Benelux countries, Austria and the UK. On leaving Nice airport, this network enables you to reach the Principality of Monaco, 22km away in less than 30 minutes, thanks to its own junction on one of the departmental coastal roads.

Between Nice and Monaco, you can also take three highly attractive roads, the “Basse Corniche” (N98), along the coast, the “Moyenne Corniche” (N7), passing through Eze Village and the “Grande Corniche”, passing through La Turbie and Col d’Eze at an altitude of 512m.

By rail All trains stop at the Monaco/Monte Carlo station. The TGVs to and from Paris (journey time 5.5 hours). Trains to Milan, Genoa or Basel during the day. Overnight trains to Strasbourg, Paris, Toulouse, Irun, Port-Bou, Milan, Venice, Pisa and Rome. Regional Express Trains which connect the towns on the Côte d’Azur.

By plane The Nice Côte d’Azur International Airport links the Principality of Monaco to more than 86 worldwide destinations. The highlight of the Côte d’Azur, the Principality of Monaco, via Nice airport (25 minutes by road, or 6 minutes by helicopter transfer) is linked daily to major European capitals and beyondtoall continents.

Bus from Nice Côte d’Azur International Airport to Monaco DIA will provide a complimentary direct shuttle between Nice Côte d’Azur International Airport and DIA’s conference hotels in Monaco.

10 Special Hotel Rates for your EuroMeeting 2010 Accommodation in Monaco

Monaco - Surprisingly Affordable Hotel Rates! Monaco hotels are ranked as some of the best in the world. DIA has negotiated special conference rates which are very competitive in comparison to many other major cities in Europe. All rates include breakfast, service and all taxes. Double and single room rates are the same.

Rooms can be reserved via the EuroMeeting 2010 website from July 6, 2009.

Please be advised that DIA has only one contracted and exclusive hotel agent for the EuroMeeting 2010: K.I.T. Group.

DIA works with one agent to ensure that: • Your hotel reservations are officially part of the EuroMeeting. • The hotels rates have been individually negotiated for the EuroMeeting and are exclusive to EuroMeeting participants. • Your hotel reservations, privacy and personal data are completely secure.

Hotel Name Room Rate incl. breakfast Distance from hotel to Convention Centre and complimentary DIA airport shuttle to hotel 4 Star Palace Hôtel de Paris 265.00 € Walking distance Hôtel Metropole Monte-Carlo 270.00 € Walking distance

4 Star Deluxe Hôtel Hermitage 209.00 € Walking distance Fairmont Monte-Carlo 203.00 € Walking distance Port Palace 213.00 € Walking distance Le Méridien Beach Plaza 203.00 € Walking distance Monte-Carlo Beach Hotel 199.00 € Walking distance Monte-Carlo Bay Hotel 199.00 € Walking distance

3 Star Deluxe Columbus Monaco 203.00 € 10 minutes by bus (complimentary hotel shuttle to the Convention Centre in the morning and evening)

3 Star Hotel Ambassador 170.00 € 5-10 minutes by bus Novotel Monte-Carlo 185.00 € Walking distance

Book your hotel room by December 4, 2009 and get the chance to win two VIP tickets for the Monaco Formula One Grand Prix (Sunday, May 24, 2010)

Book your hotel room through the EuroMeeting website and you may have a good reason to come back in May! The Grimaldi Forum Convention Centre, in partnership with the Monaco Convention Bureau, is offering you the chance to win the fantastic and exclusive prize of two tickets in their Monaco Grand Prix VIP private stand, including a welcome cocktail and lunch, if you book your hotel room through the EuroMeeting website by December 4, 2009 (17:00 CET). All conference participants who have booked their room by that date will be automatically entered into the draw.

11 Have you seen the EuroMeeting 2010 website? Simply go to www.diahome.org and click on the EuroMeeting icon.

You will be able to:

• Register for the meeting

• Get information on being an exhibitor

• Find out more about student and young professional activities

• Submit a student poster or professional poster

• Take advantage of specially-negotiated affordable hotel rates in Monaco

• Learn more about Monaco

• Get more information about networking Registration is opportunities now open! • Search for sessions and speakers

DIA has created a group on the social networking site, LinkedIn:

DIA 22nd Annual EuroMeeting, March 8-10, 2010, Monaco

• Connect with speakers, attendees and exhibitors prior to the conference

• Share ideas and experiences with colleagues in your field

• Arrange meetings and network online with fellow delegates

• Speakers will lead discussions on topics that will be covered at the EuroMeeting

• Latest news on the conference programme and confirmed speakers

• Updates on the conference networking events, hotels, travel and transport information

Visit www.linkedin.com > search groups > DIA 22nd Annual EuroMeeting