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1 EFGCP Multi-Stakeholder Workshop & Discussion on How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? Wheree do we currently stand with the implementation in different Member States 13 April 2016 MCE Conference Centre Brussels, Belgium Organised by the European Forum for Good Clinical Practice With the Partnerships -

2 Introduction EFGCP Workshop on How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? 13 April 2016, MCE Conference Centre, Brussels, Belgium - Final Programme A revision of the Clinical Trials Regulation has been adopted by European legislation makers in This revised legal framework will bring significant advances compared to todays situation and is expected to be fully implemented as soon as the supporting Clinical Trials Portal and Database are fully functional (2H2017). The opportunity of the new Regulation to improve harmonisation and competitiveness of clinical research in Europe while safeguarding patients interests must be fully carried through at the national level to enable our region to emerge as an attractive place for conducting Clinical Research. This will not only benefit commercial and non-commercial sponsors, but specifically patients who are eagerly waiting to participate in Clinical Trials and benefit from new treatment options. The new legal rules specifically mandate a closer co-ordination of clinical trial applications assessments across EU Member States, supported by much closer collaboration between the national competent authorities and the ethics committees within each Member State. EFGCP had hosted an initial workshop in September 2014 to discuss key implementation aspects with patients, academia, ethics committees, regulators and industry and share some good ideas and best practices to swiftly start the process in each country. This follow-on workshop aims now to show case the tremendous progress that has been made with the implementation over the past 18 months. The European Commission, for example, is facilitating discussions to resolve some key harmonisation questions across Europe. The EMA has made significant progress with the development of the new EU Clinical Trials Database and Portal which is the key working tool to facilitate a streamlined and swift coordination process between the various parties involved. In addition, Member States have started to develop new local procedures and initiated some early pilots to test the new assessment scenario. And finally Ethics Committees are intensifying or starting up new collaborations across countries to discuss important aspects of harmonisation of assessment criteria, methodologies and training of reviewers. Programme Committee Ingrid Klingmann Pharmaplex, European Forum for Good Clinical Practice (EFGCP), Belgium Kim Champion Hugh Davies Sini Eskola Jozef Glasa Angelika Joos Anastassia Negrouk University College London (UCL), EFGCP, United Kingdom Health Research Authority (HRA), United Kingdom European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium Slovak Medical University/Institute of Medical Ethics & Bioethics, European Forum for Good Clinical Practice (EFGCP), Slovakia Merck Sharp & Dohme, Belgium European Organisation for Research and Treatment of Cancer (EORTC), Belgium Faculty Péter Arányi Hungarian Ethics Committee for Clinical Pharmacology, Hungary Cristina Avendaño Solá Hospital Puerta de Hierro Majadahonda, Spain Kim Champion University College London (UCL), EFGCP, United Kingdom Giulio Corbelli European AIDS Treatment Group (EATG), Italy Marek Czarkowski Centre for Bioethics of Supreme Medical Council, Poland Hugh Davies Health Research Authority (HRA), United Kingdom Sini Eskola European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium Jozef Glasa Slovak Medical University/Institute of Medical Ethics & Bioethics, European Forum for Good Clinical Practice (EFGCP), Slovakia Maja Leon Grzymkowska DG Health, European Commission Joerg Hasford Ludwig-Maximilians-University of Munich, Germany Kaisa Immonen- European Patients Forum (EPF), Belgium Charalambous Angelika Joos Merck Sharp & Dohme, Belgium Page 2 of 5

3 13 April 2016, MCE Conference Centre, Brussels, Belgium - Final Programme Ingrid Klingmann François Lemaire Greet Musch Anastassia Negrouk Fabien Peuvrelle Claire Sibenaler Ernst Singer Fergus Sweeney Nick Sykes Pharmaplex, European Forum for Good Clinical Practice (EFGCP), Belgium Hôpital Henri-Mondor, Délégation Interrégionale à la Recherche Clinique (DIRC), France Federal Agency for Medicines and Health Products, Belgium European Organisation for Research and Treatment of Cancer (EORTC), Belgium Celgene, Switzerland Les Entreprises du Médicament (LEEM), France Ethics Committee of the Medical University of Vienna, Austria European Medicines Agency (EMA) Pfizer, United Kingdom Workshop Venue MCE Conference Centre Rue de l'aqueduc, Ixelles Belgium Tel: Website: Workshop Language The language of the workshop will be English. Registration & Information OPEN EVENT - conferences@efgcp.eu or visit Page 3 of 5

4 13 April 2016, MCE Conference Centre, Brussels, Belgium Final Programme Agenda Wednesday 13 th April 09:00 Registration & Welcome Coffee 09:30 Welcome, General Introduction & Aim of the Day Ingrid Klingmann, Pharmaplex, European Forum for Good Clinical Practice (EFGCP), Belgium SESSION 1: General Status of the Regulation Implementation Chairs: Angelika Joos, Merck Sharp & Dohme, Belgium & Giulio Corbelli, European AIDS Treatment Group (EATG), Italy 09:40 Keynote: Where do we stand with the implementation in Europe? Maja Leon Grzymkowska, DG Health, European Commission - What are the key questions for harmonization? - What is the implementation date? 09:55 Presentation of the Portal and Database and how it enables cooperation in the assessment and decision making process Fergus Sweeney, European Medicines Agency (EMA) - Where does the portal development stand? - How does the assessment process look in the system? - How are the various stakeholders participating? 10:25 Implementation across Europe: Summary from the EFPIA CTiMonitor quarterly survey Sini Eskola, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium 11:00 Coffee Break SESSION 2: Member State progress and early pilots Chairs: Hugh Davies, Health Research Authority (HRA), United Kingdom & Kim Champion, University College London (UCL), EFGCP, United Kingdom 11:20 The Future Approach to clinical trial application assessment How to coordinate a swift assessment? Presentations from: - Joerg Hasford,Ludwig-Maximilians-University of Munich,Germany - François Lemaire, Hôpital Henri-Mondor, Délégation Interrégionale à la Recherche Clinique (DIRC), France - Greet Musch, Federal Agency for Medicines and Health Products, Belgium Followed by Q&A discussion with the audience 12:45 Lunch Break Page 4 of 5

5 13 April 2016, MCE Conference Centre, Brussels, Belgium Final Programme Chairs: Anastasia Negrouk, European Organisation for Research and Treatment of Cancer (EORTC), Belgium & Fabien Peuvrelle, Celgene, Switzerland 13:45 The Future Approach to clinical trial application assessment How to coordinate a swift assessment? Presentations from: - Péter Arányi,Hungarian Ethics Committee for Clinical Pharmacology, Hungary (remote presentation) - Cristina Avendaño Solá, Hospital Puerta de Hierro Majadahonda, Spain - Marek Czarkowski, Centre for Bioethics of Supreme Medical Council, Poland Followed by Q&A discussion with the audience 15:10 Coffee Break SESSION 3: What else must be done to facilitate collaboration? Chairs: Jozef Glasa, Slovak Medical University/Institute of Medical Ethics & Bioethics, European Forum for Good Clinical Practice (EFGCP), Slovakia & Ingrid Klingmann, Pharmaplex, European Forum for Good Clinical Practice (EFGCP), Belgium 15:30 Panel discussion about pilot experience, ethic committee collaborations, sharing of best practices, training of assessors Panelists: Kaisa Immonen-Charalambous, European Patients Forum (EPF), Belgium Ernst Singer, Ethics Committee of the Medical University of Vienna, Austria Claire Sibenaler, Les Entreprises du Médicament (LEEM), France Nick Sykes, Pfizer, United Kingdom 16:55 Conclusions & Next Steps Ingrid Klingmann, Pharmaplex, European Forum for Good Clinical Practice (EFGCP), Belgium 17:00 End of Workshop Page 5 of 5