EVOLUTION TO THE NEXT STEP - THE NEEDS OF THE FUTURE? A joint meeting between TOPRA and the European Medicines Agency TOPRA – The Organisation for Professionals in Regulatory Affairs Reference: CA4/09 The European Medicines Agency - what will the Two-day future bring us and what do we need to know today? Conference Date: The 4th annual EMEA round-up of the year and look towards Tuesday 1st to the next year - a firm favorite with many European regulatory Wednesday 2nd affairs personnel as the key year end event to reflect on the December 2009 year gone by and to plan for the upcoming year. Venue: East Wintergarden, Who should attend? Conference working party Canary Wharf, London This conference will cover all the major ● Anthony Humphreys, Head of Sector, areas of medicines legislation covered by the Regulatory Affairs and Organisational Timings: European Medicines Agency. If you are working Support, Post-Authorisation Evaluation of 8.00 Registration at a Europe wide level then this meeting is a Medicines for Human Use, EMEA for 9.00 Start must for all levels of regulatory personnel. It ● Arielle North, Scientific Administrator, EMEA on 1st December will provide you with practical advice on the ● Agnès Saint Raymond, Head of Orphan working of the EMEA within the European 17.30 Close Drugs, Scientific Advice and Paediatric regulatory network. on 2nd December Medicines, EMEA Conference programme includes ● Tomas Salmonson, Vice Chair CHMP, Medical Products Agency (MPA), Sweden ● European Union future regulatory activity – The Pharmaceutical Package, European ● Peter Bachmann, European and International Commission update; EMEA Road map 2015; Affairs, BfArM, Germany HMA Strategy paper ● Beatrice Oberlé-Rolle, Drug Regulatory ● Pharmacovigilance and Risk Management Affairs, Nobel Biocare, Switzerland ● ● Working internationally Brenton E James, Consultant in Strategic Regulatory Affairs in Europe, UK ● Reacting and planning for change - EMEA restructuring ● Liz Gifford, Director, Global Regulatory Affairs, GlaxoSmithKline, UK ● Paediatrics - clinical studies ● Donna Mountfield, Associate Director of TOPRA/ ● Clinical Trials Regulatory Affairs, Chugai Pharma Europe, UK EMEA ● Variations * Supported by TOPRA staff 12hrs ● CHMP Lifelong learning * For more information Please note: there will be a drinks reception on the evening of the 1st December to facilitate networking please visit www.topra. For more information or a booking form, please visit www.topra.org/emea2009 org/lifelonglearning email: [email protected] tel: +44 (0) 20 7510 2560 fax: +44 (0) 20 7537 2003 web: www.topra.org TUESDAY 1ST DECEMBER 2009 WEDNESDAY 2ND DECEMBER 2009 09.00 Welcome and Introduction from Paolo Biffignandi, TOPRA 11.4 0 Hot Topics - Peter Arlett, Head of Sector Pharmacovigilance 08.30 Opening Remarks Chaired by President, VI.REL Pharma S.a.s., Italy and Thomas Lönngren, and Risk Management, EMEA Peter Bachmann, European and International Affairs, BfArM, Germany Executive Director, European Medicines Agency 12.00 Implementation of Development Safety Update Reports SESSION 5 Hilde Boone, Scientific Administrator, EMEA (DSURs) in Europe - Barry Arnold, EU Qualified Person for Paediatrics – clinical studies 13.15 Introduction: Background and future work sharing - Peter SESSION 1 Pharmacovigilance, AstraZeneca R & D, UK This session will review the type of clinical trials that are usually included Bachmann and Hilde Boone European Union: The latest information on future 12.20 EU Risk Management Plans (RMP) - Stella Blackburn, Risk Management Coordinator, EMEA in Paediatric Investigations Plans, discuss aspects related to study 14.05 Industry viewpoint on work sharing - Fiona Reekie, Director, regulatory activity for pharmaceuticals feasibility from the view of sponsors and agencies and give advice on the Johnson & Johnson Pharmaceuticals, UK 12.40 Speaker Panel with this sessions’ speakers In the near future significant developments proposed by the set-up and conduct of long-term safety monitoring in children. 14.15 Speaker Panel with this sessions’ speakers 13.00 L u n c h European Commission, the European Medicines Agency and the Chaired by 14.45 Tea and Coffee Heads of Human Medicines Agencies will be released and have a very Agnès Saint Raymond, Head of Orphan Drugs, Scientific Advice and important impact on all stakeholders involved in Medicinal Products. SESSION 3 Paediatric Medicines, EMEA This session includes an update on the Pharmaceutical Package, the Working internationally SESSION 8 EMEA Road Map to 2015 and the Heads of Medicines Agencies Angelika Joos, Director Regulatory Policy Europe, Merck Sharp & Dohme Committee for Medicinal Products for Human Use Strategy Paper. This session will explore working internationally with recent initiatives in (Europe) Inc, Belgium (CHMP) – achievements and challenges the areas of transatlantic cooperation, Bilateral agreements (Japan, US, 08.40 Overview of clinical studies in Paediatric Investigation Plans (PIPs) Chaired by Canada etc), Clusters and with specific examples such as GMP and GCP. This session will review the operation of the CHMP within the European Irene Sacristan-Sanchez, Deputy Head DG Enterprise and Industry, 09.00 Are Paediatric trials feasible? regulatory network. Subjects to be covered by key speakers from Chaired by Pharmaceuticals Unit, European Commission 09.20 How to establish long-term safety in children? Regulatory Agencies (including the CHMP Chair) include the CHMP's Emer Cooke, International Liaison Officer, EMEA Brenton James, Consultant in European Regulatory Affairs in Europe, UK 09.40 Speaker Panel with this sessions’ speakers current activities and workload, it's achievements and successes and Tomas Salmonson, Vice Chair CHMP, Medical Products Agency (MPA), Sweden the way it interacts with other key committees and stakeholders (e.g. 10.15 Tea and Coffee 09.20 Introduction to this session - Brenton James, Consultant in CAT, PDCO, SAGs). The session will include discussion on some of the 14.00 Bilateral agreements and clusters - Emer Cooke, International European Regulatory Affairs in Europe, UK hot topics associated with the Centralised Procedure (e.g. Rapporteur Liaison Officer, EMEA 09.25 The Pharmaceutical Package - Irene Sacristan-Sanchez, Deputy SESSION 6 selection, the contribution of peer review and SAGs, transparency) and 14.20 Inspections, GCP and clinical trials Head DG Enterprise and Industry, Pharmaceuticals Unit, Clinical Trials will discuss some of the challenges that face the CHMP in the future European Commission 14.40 GMP - Oliver Gross, Scientific Administrator, EMEA with the Centralised Procedure. An example of a successful Centralised This session will review the state and recent developments in relation to 09.45 The EMEA Road Map to 2015 - Noel Wathion, Head of unit 15.00 Speaker Panel with this sessions’ speakers Procedure will be presented by an industry speaker. the conduct of clinical trials across the EU. The achievements within the Patient Health Protection, EMEA 15.30 Tea and Coffee voluntary harmonisation procedure will be reviewed as well as general Chaired by 10.05 Heads of Medicines Agencies Strategy Paper - Marcus Müllner, observations in relation to safety reporting and issue assessment. Eric Abadie, Chair of CHMP, Agence Française de Sécurité Sanitaire des Division Manager, AGES PharmMed/Austrian Medicines and Produits de Santé (Afssaps), France Medical Devices Agency, Austria SESSION 4 Chaired by Reacting and planning for change – Liz Gifford, Director, Global Regulatory Affairs GlaxoSmithKline, UK 10.25 Speaker Panel with this sessions’ speakers and invited panellist: Beatrice Oberlé-Rolle, Drug Regulatory Affairs, Nobel Biocare, Switzerland EMEA restructuring 15.15 Introduction by the Chair of CHMP - Eric Abadie, Chair of Judith Creba, Head of EU Liaison and Policy, Novartis, 10.15 Introduction Switzerland will comment upon the presentations and all CHMP, Agence Française de Sécurité Sanitaire des Produits de This session will review the recent reorganisation of the EMEA, the 10.55 Clinical Trial Harmonisation - Hartmut Krafft, Head of sector, attendees are invited to ask questions of the speakers. Santé (Afssaps), France reasons for this and the impact on stakeholders such as Heads of clinical trials, Paul-Ehrlich-Institut (PEI), Germany 11.0 0 Coffee break Medicines Agencies (HMA) and the impact on resources and training. 15.30 CHMP Work Load – Anthony Humphreys, Head of Sector, 11.15 CTFG activities - Chantal Bélorgey, Head of Division on Regulatory Affairs and Organisational Support, Post- Chaired by Evaluation of Special Status Medicinal Products and Clinical Authorisation Evaluation of Medicines for Human Use, EMEA trials, Afssaps, France SESSION 2 Arielle North, Scientific Administrator, EMEA 15.50 Committees and Working Parties - Xavier Luria Oller, Head of Pharmacovigilance and Risk Management Pat O'Mahony, Chair of EMEA Management Board, Chief Executive 11. 35 Industry observations Sector, Safety and Efficacy of Medicines, EMEA This session will cover new regulatory developments within the area Officer of IMB, Ireland 11.45 Tranparency of Clinical Trials 16.10 Special Projects - Eric Abadie, Chair of CHMP, Agence Française of Pharmacovigilance. Topics to be covered in this session include 16.00 EMEA Reorganisation - Patrick Le Courtois, Head of Unit, 12.15 L u n c h de Sécurité Sanitaire des Produits de Santé (Afssaps), France updates on topics such as ICH and CIOMS, the implementation of the Human Medicines Development