Introduction to Regulatory Affairs 2025
Schedule of Introduction to Regulatory Affairs 2025
| Day 1, Monday, November 24 | |
| 8:30 - 9:00 | Registration and coffee |
| 9:00 - 9:15 | Welcome & introduction to the course by Marc Benijts (HEALIXIA) |
| 9:15 - 10:15 | Pharmaceuticals – definitions – product life cycle by Sofie Starckx (Johnson & Johnson Innovative Medicine) |
| 10:15 - 11:15 | The European Union and its institutions – The Belgian bodies by Peter Bogaert & Lucas Michel (Covington & Burling LLP) |
| 11:15 - 11:45 | Coffee break |
| 11:45 - 12:45 | The pharmaceutical legislation (EU – B) by Peter Bogaert & Lucas Michel (Covington & Burling LLP) |
| 12:45 - 13:45 | Lunch break |
| 13:45 - 14:45 | European Medicines Agency – EU procedures for Marketing Authorizations - part 1 by An Van Hemelrijck (PhaRA consulting) |
| 14:45 - 15:00 | Coffee break |
| 15:00 - 15:45 | European Medicines Agency – EU procedures for Marketing Authorizations - part 2 by An Van Hemelrijck (PhaRA consulting) |
| 15:45 - 17:00 | Pharmacovigilance by Begum Benli Peker & Aline Poliart (BMS) |
| Day 2, Tuesday, November 25 | |
| 8:30 - 9:00 | Registration and coffee |
| 9:00 - 10:15 | Legislation for clinical trials - Speaker TBC (FAMHP) |
| 10:15 - 10:30 | Coffee break |
| 10:30 - 11:30 | Marketing Authorization – Legal basis – Practical aspects linked to module 1 by Karolina Szlufcik (FAMHP) |
| 11:30 - 12:30 | CTD module 3 by Evelien Wynendaele (UGent) |
| 12:30 - 13:15 | Lunch break |
| 13:15 - 14:30 | CTD module 4 by Gaëlle De Meyer (FAMHP) |
| 14:30 - 15:45 | CTD module 5 by Nele Berthels (FAMHP) |
| 15:45 - 16:00 | Coffee break |
| 16:00 - 17:30 | Variations – renewals – extensions by Jeroen de Wilt (Merck Sharp & Dohme Europe) |
| 17:30 - 17:45 | Closing remarks by Marc Benijts (HEALIXIA) |