CLINICAL TRIAL MANAGEMENT & REGULATORY AFFAIRS in Pharma, Biotech, Medtech Domains

Transcription

1 CLINICAL TRIAL MANAGEMENT & REGULATORY AFFAIRS in Pharma, Biotech, Medtech Domains May 10-12, 2016 at EPFL, Odyssea Building, level minus 1, classroom Module Leaders Thomas Girard, 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.

2 Clinical Trial Management & Regulatory Affairs Tue :15-12:45 Thomas Girard, 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

3 Clinical Trial Management & Regulatory Affairs Medtech track Tue :15-15:15 16:00-17:45 Eric Klasen Vice President, Regulatory Affairs & Quality Medtronic Int l Trading sàrl Andrea Sparti Regulatory Affairs Manager, Medtronic Int l Trading s4rl Introduction to MedTech Pre-Market Part I - Classification & Exercise Pre-Market Part II - Tech file & Design dossier - Conformity Assessment Routes - Standards - Post-Market Surveillance 09:15-12:45 Benedict Brown Reimbursement Director Medtronic Int l Trading sàrl Market access for medical devices Reimbursement and Health Technology Assessment 14:15-17:30 Nikolaos Stergiopulos Professor EPFL CEO, RHEON Medical Developing Medical Technology: From the Academic Lab to Clinical Practice

4 Clinical Trial Management & Regulatory Affairs Medtech track 9:15-12:30 Anna Pietersma Principal Consultant Qserve Consultancy BV 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 14:00-16:45 Maura Arsiero, PhD Director Business Development Second Sight Medical Products Case Study: Second Sight 17:00-17:15 Participants Evaluation Multiple choice questionnaire 17:15-17:30 Eric Klasen Wrap-up

5 Clinical Trial Management & Regulatory Affairs Biotech - Pharma track Tue :15-16:45 16: Marie Mellody/Angela Piazzi Managing Directors, Virtuoso Participants The Clinical Development External Environment Good Practices and Regulations and Regulated Inspections Read in advance A Vision for the Future Genomics Review in advance the video link Team break-out discussions and presentations back to the group 09:15-12:45 Andrew Galazka Senior VP Global Medical Affairs, Merck Serono Case Studies: Examples of Product Development from the world of Biotechnology Part I Read in advance Case study in oncology Group discussion and interaction

6 Clinical Trial Management & Regulatory Affairs Biotech - Pharma track 14: Andrew Galazka Senior VP Global Medical Affairs, Merck Serono Case study and drug development discussion Part II Group discussion and interaction 09: Marie Mellody Managing Director, Virtuoso Clinical Development Process Overview, Market Access and life cycle management research Group discussion and interaction Participants 14: 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 17:00-17:30 Participants Evaluation Pharma Track Multiple choice questionnaire

7 Clinical Trial Management & Regulatory Affairs Course material Day 1 - Morning Chapter 1, Marketing Authorisation, Health and Food Safety Directorate-General, European Commission, July 2015 Day 1, 2 & 3 Medtech Track Interim Results from the International Trial of Second Sight s Visual Prosthesis, by Mark S. Humayun et al by the American Academy of Ophthalmology Day 1, 2 & 3 Biotech-Pharma Track A Vision for the Future Genomics Case study in oncology Lecturers presentations, articles, case studies and other documents will also be provided during class for both the Medtech and Biotech Track.