2 5 TH A NNU A L EUROMeeTING AMSTERDam 2013 4-6 March 2013 RAI, Amsterdam, Netherlands Final Programme 2 TABLE OF CONTENTS Continuing Professional Development Credits .............................................................. 2 Theme 8 | eTools and Data Management ............................................................... 34-35 Programme Advisors ............................................................................................................. 2 Theme 9 | Involvement of Experts in the Drug Approval Process .................35-36 Welcome from the EuroMeeting 2013 Co-Chairs .......................................................... 3 Theme 10 | Known Active Substances ..................................................................... 36-38 EuroMeeting 2013 Theme Leaders ....................................................................................4 Theme 11 | Antibiotics/Anti-Infective Treatments ................................................ 38-39 Schedule at-a-glance ............................................................................................................. 5 Theme 12 | Effectiveness and Efficiency of the EU Regulatory System .........39-41 General Information ........................................................................................................... 6-7 Theme 13 | Globalisation ...............................................................................................41-42 Opening Plenary .....................................................................................................................6 Theme 14| Regulatory Science ..........................................................................................43 Special Sessions ......................................................................................................................9 Theme 15 | Demand for Quantitative Approaches in Drug Development ................. 44 DIA Award Winners .............................................................................................................. 10 Theme 16 | Developments in Non-Clinical .....................................................................45 Posters/Student Sessions/Young Professionals Sessions ....................................12-13 Theme 17 | The IMI Public Private Partnership in Medicines Research Education Fellowship Programmes ................................................................................................ 14-15 and Training – for Professionals and for Patients ....................................................... 46 Pre-Conference Tutorials ..............................................................................................16-21 Hot Topics and Stand-Alone Sessions ..................................................................... 47-48 Theme 1 | Health Technology Assessment (HTA) .............................................. 22-23 Glossary of Terms .................................................................................................................49 Theme 2 | Special Populations ................................................................................ 23-25 Speaker Index ................................................................................................................. 50-57 Theme 3 | Legal/Transparency-Risk Assessment ................................................25-26 Networking Events ..............................................................................................................58 Theme 4 | Pharmacovigilance ................................................................................... 27-28 Exhibition ..........................................................................................................................59-73 Theme 5 | Clinical Research and Development .................................................... 28-29 EuroMeeting Session Plan ...........................................................................................78-80 Theme 6 | Quality ...........................................................................................................30-31 Theme 7 | Devices and Combination Products ......................................................32-33 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 25th Annual EuroMeeting has been awarded 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 200 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 Advisors Angelika Joos, Director, Head Regulatory Policy, EU & Most of World, Merck Sharp & Dohme (Europe) Inc., Belgium Aginus Kalis, Chair HMA, Executive Director, Medicines Evaluation Board, Netherlands Catherine Levinson-Bates, Manager Patient Advocacy, Merck Serono, Switzerland Beatriz Silva Lima, CHMP and SAWP Member, SWP Chair; Professor, Pharmacology, Faculty of Pharmacy, University of Lisbon, Portugal EUROMEETING 2013 Co-Chairs’ MESSAGE 3 Welcome from the EuroMeeting 2013 Co-Chairs Dear Colleague, We are delighted to welcome you to the 25th DIA Annual EuroMeeting! Amsterdam is the ultimate “small big city” and combines all the advantages of a cosmopolitan capital with a compact, easy-to-navigate size which translates in less time spent in commuting and more time enjoying what the city has to offer. The city has a rich cultural heritage and 2013 is a year to celebrate important events there. Besides the 400-year anniversary of the Canal Ring, Amsterdam will be celebrating the re-opening of the fully renovated Rijksmuseum, the 125th anniversary of the Concertgebouw (concert hall) and the Royal Concertgebouw Orchestra, the 225th anniversary of Felix Meritis conference and event centre, and the 175th anniversary of Artis Royal Zoo. With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the EuroMeeting 2013 are classified into general disciplines including pharmacovigilance and regulatory affairs for medicinal products and medical devices, R&D and clinical trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate. By 2013, the new Pharmacovigilance Directive will have been in place for almost a year; knowing what still needs to be done - or improved, and most importantly: are we getting what was initially expected? These are some of the key areas that the professionals attending the meeting will be able to learn about and debate. Other important topics to be covered include the Falsified Medicines Directive, the Information to Patients – what is the status? - the role played by scientific societies as experts, and considerations over an ageing population and the potential impact on hospitalisations. With such an appealing outline of topics, we look forward to fruitful and engaging discussions that serve to improve further our healthcare systems and warmly welcome your participation. Beatriz Vicén Banzo and Peter Bachman Beatriz Vicén Banzo Mrs. Vicén has been Head of Public Affairs and Technical Department in Bayer Spain since July 2011. She qualified as pharmacist with specialisation in Biochemistry in 1988. In addition she has a Master in Business Administration of the Pharmaceutical Industry from the University of Barcelona (1992), a Master in European Regulatory Procedures from the Autonomous University of Barcelona (1999), and a Master in Business Administration from the Business School ESADE (2005) Barcelona, Spain. Mrs. Vicén was Head of Regulatory Affairs in Novartis Pharma (Spain) until 2008, and Head of Regulatory Affairs and Quality Assurance in Bayer Spain until June 2010. Peter Bachmann Peter Bachmann is the recently appointed Chair of The Co-ordination Group for Mutual Recognition