Monaco 2010 PRELIMINARY PROGRAMME
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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 Cover Image: Roger Broders, “La Corne d’Or Nice Villefranche Monaco” - © 2009 ProLitterus, Zurich 2 Welcome from the EuroMeeting 2010 Co-Chairs Bruno Flamion and Kerstin Franzén 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