| 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)
|
