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FAMHP

Introduction to Regulatory Affairs 2024

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, November 25

  2. -

    • Registration and coffee

  3. -

    • Welcome & introduction to the course (Marc Benijts - Healixia)

  4. -

    • Pharmaceuticals – definitions – product life cycle - (Sofie Starckx - Johnson & Johnson Innovative Medicine)

  5. -

    • The European Union and its institutions – The Belgian bodies (Peter Bogaert & Lucas Michel - Covington & Burling LLP)

  6. -

    • Coffee break

  7. -

    • The pharmaceutical legislation (EU – B) (Peter Bogaert & Lucas Michel - Covington & Burling LLP)

  8. -

    • Lunch

  9. -

    • European Medicines Agency – EU procedures for Marketing Authorizations - part 1 (An Van Hemelrijck - PhaRA consulting)

  10. -

    • Coffee break

  11. -

    • European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (An Van Hemelrijck - PhaRA consulting)

  12. -

    • Pharmacovigilance (Begum Benli Peker – Bristol Myers Squibb)

  13. Day 2, Tuesday, November 26

  14. -

    • Legislation for clinical trials (Anne Lenaers - FAMHP)

  15. -

    • Coffee break

  16. -

    • Marketing Authorization – Legal basis – Practical aspects linked to module 1 (Karolina Szlufcik - FAMHP)

  17. -

    • CTD module 3 (Evelien Wynendaele - UGent)

  18. -

    • Lunch

  19. -

    • CTD module 4 (Gaëlle De Meyer - FAMHP)

  20. -

    • CTD module 5 (Nele Berthels - FAMHP)

  21. -

    • Coffee break

  22. -

    • Variations – renewals – extensions (Bruna Rodrigues & Sofie Deroover - Merck Sharp & Dohme Europe)

  23. -

    • Closing remarks (Marc Benijts - Healixia)

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Schedule of Introduction to Regulatory Affairs 2024