| Day 1, Monday, September 28 |
| 8:30 - 9:00 |
Registration and coffee
|
| 9:00 - 9:15 |
Welcome & introduction to the course - Marc Benijts
|
| 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 (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP)
|
| 11:15 - 11:45 |
Coffee break
|
| 11:45 - 12:45 |
The pharmaceutical legislation (EU - B) - Peter Bogaert (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP)
|
| 12:45 - 13:45 |
Lunch
|
| 13:45 - 14:45 |
European Medicines Agency - EU procedures for Marketing Authorisations - part 1 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA)
|
| 14:45 - 15:00 |
Coffee break
|
| 15:00 - 15:45 |
European Medicines Agency - EU procedures for Marketing Authorisations - part 2 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA)
|
| 15:45 - 17:00 |
Pharmacovigilance - Ellen Felix (Pfizer)
|
| Day 2, Tuesday, September 29 |
| 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 - Sarah Skouta (Merck Sharp & Dohme Europe)
|
| 16:00 - 16:15 |
Coffee break
|
| 16:15 - 17:15 |
Marketing Authorisation - Legal basis - Practical aspects linked to module 1 - Nicolas Nyssen (FAMHP) & Machteld Verbruggen (FAMHP)
|
| 17:15 - 17:30 |
Closing remarks - Marc Benijts (Healixia)
|
