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Online FAMHP

Introduction to Regulatory Affairs 2020 (complete)

The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

  1. Day 1, Monday, September 28

  2. 8:30 - 9:00

    • Registration and coffee

  3. 9:00 - 9:15

    • Welcome & introduction to the course - Marc Benijts

  4. 9:15 - 10:15

    • Pharmaceuticals - definitions - product life cycle - Lieve Lammens (Janssen Research and Development)

  5. 10:15 - 11:15

    • The European Union and its institutions - The Belgian bodies - Peter Bogaert (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP)

  6. 11:15 - 11:45

    • Coffee break

  7. 11:45 - 12:45

    • The pharmaceutical legislation (EU - B) - Peter Bogaert (Covington & Burling LLP) - Bart Van Vooren (Covington & Burling LLP)

  8. 12:45 - 13:45

    • Lunch

  9. 13:45 - 14:45

    • European Medicines Agency - EU procedures for Marketing Authorisations - part 1 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA)

  10. 14:45 - 15:00

    • Coffee break

  11. 15:00 - 15:45

    • European Medicines Agency - EU procedures for Marketing Authorisations - part 2 - Ingrid Theewes (PhaRA) & Frank Vandendriessche (PhaRA)

  12. 15:45 - 17:00

    • Pharmacovigilance - Ellen Felix (Pfizer)

  13. Day 2, Tuesday, September 29

  14. 9:00 - 10:15

    • Legislation for clinical trials - Benedikt Van Nieuwenhove (European Centre for Clinical Research - ECCRT)

  15. 10:15 - 10:45

    • Coffee break

  16. 10:45 - 11:45

    • CTD module 3 - Evelien Wynendaele (UGent)

  17. 11:45 - 12:45

    • CTD module 4 - Gaëlle De Meyer (FAMHP)

  18. 12:45 - 13:45

    • Lunch

  19. 13:45 - 14:45

    • CTD module 5 - Nele Berthels (FAMHP)

  20. 14:45 - 16:00

    • Variations - renewals - extensions - Sarah Skouta (Merck Sharp & Dohme Europe)

  21. 16:00 - 16:15

    • Coffee break

  22. 16:15 - 17:15

    • Marketing Authorisation - Legal basis - Practical aspects linked to module 1 - Nicolas Nyssen (FAMHP) & Machteld Verbruggen (FAMHP)

  23. 17:15 - 17:30

    • Closing remarks - Marc Benijts (Healixia)

Back to overview

Schedule of Introduction to Regulatory Affairs 2020 (complete)