Introduction to Regulatory Affairs 2021

Monday, October 4, 2021 from 8:30 AM to 5:00 PM, Tuesday, October 5, 2021 from 9:00 AM to 5:30 PM Regulatory Affairs

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)