Introduction to Regulatory Affairs 2023
Schedule of Introduction to Regulatory Affairs 2023
| Day 1, Monday, December 11 | |
| 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 - (Sofie Starckx - Janssen Research & 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 - PhaRA consulting) |
| 14:45 - 15:00 | Coffee break |
| 15:00 - 15:45 | European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (Ingrid Theeuwes - PhaRA consulting) |
| 15:45 - 17:00 | Pharmacovigilance (Aline Poliart – Bristol Myers Squibb) |
| Day 2, Tuesday, December 12 | |
| 9:00 - 10:15 | Legislation for clinical trials (Anne Lenaers - FAMHP) |
| 10:15 - 10:30 | Coffee break |
| 10:30 - 11:30 | CTD module 3 (Evelien Wynendaele - UGent) |
| 11:30 - 12:30 | CTD module 4 (Gaëlle De Meyer - FAMHP) |
| 12:30 - 13:15 | Lunch |
| 13:15 - 14:30 | CTD module 5 (Nele Berthels - FAMHP) |
| 14:30 - 15:45 | Marketing Authorization – Legal basis – Practical aspects linked to module 1 (Karolina Szlufcik & Machteld Verbruggen - FAMHP) |
| 15:45 - 16:00 | Coffee break |
| 16:00 - 17:30 | Variations – renewals – extensions (Amy Hughes - Merck Sharp & Dohme Europe) |
| 17:30 - 17:45 | Closing remarks (Marc Benijts - Healixia) |