CLINICAL TRIAL MANAGEMENT & REGULATORY AFFAIRS in Pharma, Biotech, Medtech Domains April 28-30, 2015 EPFL Quartier de l Innovation, Bâtiment E, 1st floor Module Leaders Christelle Bouygues, Regulatory Affairs Officer, Regulatory Affairs Office, Regulatory, Science and Innovation Support Department, at the European Medicines Agency, EMA, London Eric Klasen, VP Regulatory Affairs & Quality, Europe & Emerging Markets, Medtronic (Medtech track) & Team Andrew Galazka, Senior VP Global Medical Affairs, Merck Serono, Aubonne (Biotech-Pharma track) Marie Mellody & Angela Piazzi, Founders & Managing Directors, Virtuoso Sarl and Inovaclin Sarl (Biotech-Pharma track) Objectives To develop understanding and competencies in planning, conduct and management of clinical trials, in good practices, regulations and approvals by addressing topics such as: Clinical Research & Product Development Pharma, Biotech and Medtech The Clinical Trial process concept to conclusion and the management of the key operational challenges Pharmaceuticals and Medical Devices in the world more particularly in Europe and Switzerland Legislative framework and procedures Marketing authorization applications and approvals Activities under national responsibilities (pricing, reimbursement, advertising, follow up of medicines sales) New emerging therapies (cell therapy, gene therapy, etc) Overview The topics mentioned above will be addressed both from the view of a Regulatory agency and from the Pharma, Biotech and Medtech perspectives. It will be illustrated with real examples. After a first common morning on Regulatory Affairs Tuesday, there will be two tracks, either Biotech-Pharma track or Medtech track. (Participants have to choose in advance which tack they wish to follow). Evaluation Participants will be evaluated according to their answers to comprehensive multiple choice questionnaires.
Clinical Trial Management & Regulatory Affairs Tue 28.04.2015 9:15-12:45 Christelle Bouygues, Regulatory Affairs Officer The European Medicines Agency EMA, London 1) The European system for medicinal products, 2) New incentives to Pharmaceutical Development SME; Orphans; Scientific Advice; Protocol Assistance; Paediatric Medicines; Advanced Therapies 3) Trends in European Submissions Trends in EU Marketing Authorisation ; Generic/Hybrid/Biosimilar medicinal products ; Non-prescription medicinal products 4) Post-authorisation activities: Concepts of grouping, work sharing, new classification introduced since January 2010 resulting from the new Variation Regulation EC/1234/2008.Other post-authorisation procedures (PSUR, renewal, etc) 5) Influence of HTA on Regulatory Decision making Lunch 12:45 14:15
Clinical Trial Management & Regulatory Affairs Medtech track Tue 28.04.2015 14:15-15:15 Eric Klasen Vice President, Regulatory Affairs & Quality Medtronic Int l Trading sàrl Introduction to MedTech 16:00-17:45 Andrea Sparti Regulatory Affairs Manager, Medtronic Int l Trading s4rl Pre-Market Part I - Classification & Exercise Pre-Market Part II - Tech file & Design dossier - Conformity Assessment Routes - Standards - Post-Market Surveillance 09:15-12:30 Danielle Giroud Founder WMDO Clinical Evidence for Medical Devices - Global Clinical Strategy - Clinical Evaluation - Clinical Study Design for Market Access - Clinical Study management You will be asked to make a 5-10 minutes presentation on your approach to clinical development Maura Arsiero, PhD Case Study: Second Sight 14:15-17:30 Country Manager Second Sight Medical Products Sàrl
Clinical Trial Management & Regulatory Affairs Medtech track 9:15-12:30 Benedict Brown Reimbursement Director Medtronic Int l Trading sàrl Market access for medical devices Reimbursement and Health Technology Assessment 12:45 14:15 Lunch 14:15-15:00 Matthias Buerger Vice President Quality Assurance & Regulatory Affairs Zimmer GmbH Introduction to Orthopedics and the Case Study 15:00-16:00 Breakout groups 16:00-16:45 Feedback discussion 17:00-17:15 Participants Evaluation Multiple choice questionnaire 17:15-17:30 Eric Klasen Wrap-up
Clinical Trial Management & Regulatory Affairs Biotech - Pharma track Tue 28.04.2015 14:15-16:45 Marie Mellody Managing Director, Virtuoso The Clinical Development Process Overview late phases of development and life cycle management Read in advance A Vision for the Future Genomics Prepare case studies in teams based on prereading of current considerations in drug development 16:45 17.45 Participants Team break-out discussions and presentations back to the group 09:15-12:45 Angela Piazzi Managing Director, Virtuoso The Current Environment for Clinical Operations and the Clinical Trial Operations Overview Team break-out discussions on clinical operations issues and presentations back to the group
Clinical Trial Management & Regulatory Affairs Biotech - Pharma track 14:15-17.45 Andrew Galazka Senior VP Global Medical Affairs, Merck Serono Case Studies: Examples of Product Development from the world of Biotechnology Part I Group discussion and interaction 09:15-12.45 Andrew Galazka Senior VP Global Medical Affairs, Merck Serono Case study and drug development discussion Part II Group discussion and interaction 12:45 14:15 Lunch 14:15-16.45 Andrew Galazka Senior VP Global Medical Affairs, Merck Serono Case study and drug development discussion Part III Group discussion and interaction 17:00-17:30 Participants Evaluation Pharma Track Multiple choice questionnaire
Clinical Trial Management & Regulatory Affairs Course material Day 1, 2 & 3 Medtech Track Interim Results from the International Trial of Second Sight s Visual Prosthesis, by Mark S. Humayun et al. 2011 by the American Academy of Ophthalmology Day 1, 2 & 3 Biotech-Pharma Track A Vision for the Future Genomics Lecturers presentations, articles, case studies and other documents will also be provided during class for both the Medtech and Biotech Track.