Introduction to Regulatory Affairs 2025

Monday, December 1, 2025 from 8:30 AM to 5:00 PM, Tuesday, December 2, 2025 from 8:30 AM to 5:45 PM Regulatory Affairs

Schedule of Introduction to Regulatory Affairs 2025

Day 1, Monday, December 1
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 & Spiros Drosos (Covington & Burling LLP)
11:15 - 11:45 Coffee break
11:45 - 12:45 The pharmaceutical legislation (EU – B) by Peter Bogaert & Zoé Bertrand (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, December 2
8:30 - 9:00 Registration and coffee
9:00 - 10:15 Legislation for clinical trials - Jeroen De Roeck (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 - 12:45 CTD module 5 by Nele Berthels (FAMHP)
12:45 - 13:30 Lunch break
13:30 - 14:30 CTD module 4 by Gaëlle De Meyer (FAMHP)
14:30 - 15:30 CTD module 3 by Evelien Wynendaele (UGent)
15:30 - 16:00 Coffee break
16:00 - 17:30 Variations – renewals – extensions by Jeroen de Wilt (MSD B.V., The Netherlands)
17:30 - 17:45 Closing remarks by Marc Benijts (HEALIXIA)