Introduction to Regulatory Affairs 2020 (complete)
Schedule of Introduction to Regulatory Affairs 2020
| Day 1, Monday, September 28 | |
| 8:30 - 9:00 | Registration and coffee |
| 9:00 - 9:15 | Welcome & introduction to the course - Marc Benijts |
| 9:15 - 10:15 | Pharmaceuticals - definitions - product life cycle - Lieve Lammens (Janssen Research and Development) |
| 10:15 - 11:15 | The European Union and its institutions - The Belgian bodies - Peter Bogaert (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP) |
| 11:15 - 11:45 | Coffee break |
| 11:45 - 12:45 | The pharmaceutical legislation (EU - B) - Peter Bogaert (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP) |
| 12:45 - 13:45 | Lunch |
| 13:45 - 14:45 | European Medicines Agency - EU procedures for Marketing Authorisations - part 1 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA) |
| 14:45 - 15:00 | Coffee break |
| 15:00 - 15:45 | European Medicines Agency - EU procedures for Marketing Authorisations - part 2 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA) |
| 15:45 - 17:00 | Pharmacovigilance - Ellen Felix (Pfizer) |
| Day 2, Tuesday, September 29 | |
| 9:00 - 10:15 | Legislation for clinical trials - Benedikt Van Nieuwenhove (European Centre for Clinical Research - ECCRT) |
| 10:15 - 10:45 | Coffee break |
| 10:45 - 11:45 | CTD module 3 - Evelien Wynendaele (UGent) |
| 11:45 - 12:45 | CTD module 4 - Gaëlle De Meyer (FAMHP) |
| 12:45 - 13:45 | Lunch |
| 13:45 - 14:45 | CTD module 5 - Nele Berthels (FAMHP) |
| 14:45 - 16:00 | Variations - renewals - extensions - Sarah Skouta (Merck Sharp & Dohme Europe) |
| 16:00 - 16:15 | Coffee break |
| 16:15 - 17:15 | Marketing Authorisation - Legal basis - Practical aspects linked to module 1 - Nicolas Nyssen (FAMHP) & Machteld Verbruggen (FAMHP) |
| 17:15 - 17:30 | Closing remarks - Marc Benijts (Healixia) |