Introduction to Regulatory Affairs 2021
Schedule of Introduction to Regulatory Affairs 2021
| Day 1, Monday, October 4 | |
| 8:30 - 9:00 | Registration and coffee |
| 9:00 - 9:15 | Welcome & introduction to the course (Marc Benijts - Healixia) |
| 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 & Bart Van Vooren (Covington & Burling LLP) |
| 11:15 - 11:45 | Coffee break |
| 11:45 - 12:45 | The pharmaceutical legislation (EU – B) (Peter Bogaert & Bart Van Vooren - Covington & Burling LLP) |
| 12:45 - 13:45 | Lunch |
| 13:45 - 14:45 | European Medicines Agency – EU procedures for Marketing Authorizations - part 1 (Ingrid Theeuwes & Frank Vandendriessche - PhaRA consulting) |
| 14:45 - 15:00 | Coffee break |
| 15:00 - 15:45 | European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (Ingrid Theeuwes & Frank Vandendriessche - PhaRA consulting) |
| 15:45 - 17:00 | Pharmacovigilance (Katrien Solemé – Bristol Myers Squibb) |
| Day 2, Tuesday, October 5 | |
| 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 (Speaker: Tatia Gartner & Olivier Novent - Merck Sharp & Dohme Europe) |
| 16:00 - 16:15 | Coffee break |
| 16:15 - 17:15 | Marketing Authorization – Legal basis – Practical aspects linked to module 1 (Nicolas Nyssen & Machteld Verbruggen - FAMHP) |
| 17:15 - 17:30 | Closing remarks (Marc Benijts - Healixia) |