08:30 - 09:00

• Registration and coffee

09:00 - 09:15

• Welcome & introduction to the course by Marc Benijts (HEALIXIA)

09:15 - 10:15

• Pharmaceuticals – definitions – product life cycle by TBC (Johnson & Johnson Innovative Medicine)

10:15 - 11:15

• The European Union and its institutions – The Belgian bodies by Spiros Drosos (Covington & Burling LLP)

11:15 - 11:45

• Coffee break

11:45 - 12:45

• The pharmaceutical legislation (EU – B) by 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 Begüm Benli Peker & Aline Poliart (BMS)

08:30 - 09:00

• Registration and coffee

09:00 - 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 - 13:15

• Lunch break

13:15 - 14:30

• CTD module 4 by TBC (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 TBC (MSD)

17:30 - 17:45

• Closing remarks by Marc Benijts (HEALIXIA)