Day 1, Thursday, November 17 |
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 (Aline Poliart – Bristol Myers Squibb)
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Day 2, Friday, November 18 |
9:00 - 10:15 |
Legislation for clinical trials (Anne Lenaers - FAMHP)
|
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 (Sofie Langereis - 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)
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