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FAMHP

Introduction to Regulatory Affairs 2023

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, December 11

  2. -

    • Registration and coffee

  3. -

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

  4. -

    • Pharmaceuticals – definitions – product life cycle - (Sofie Starckx - Janssen Research & Development)

  5. -

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

  6. -

    • Coffee break

  7. -

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

  8. -

    • Lunch

  9. -

    • European Medicines Agency – EU procedures for Marketing Authorizations - part 1 (Ingrid Theeuwes - PhaRA consulting)

  10. -

    • Coffee break

  11. -

    • European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (Ingrid Theeuwes - PhaRA consulting)

  12. -

    • Pharmacovigilance (Aline Poliart – Bristol Myers Squibb)

  13. Day 2, Tuesday, December 12

  14. -

    • Legislation for clinical trials (Anne Lenaers - FAMHP)

  15. -

    • Coffee break

  16. -

    • CTD module 3 (Evelien Wynendaele - UGent)

  17. -

    • CTD module 4 (Gaëlle De Meyer - FAMHP)

  18. -

    • Lunch

  19. -

    • CTD module 5 (Nele Berthels - FAMHP)

  20. -

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

  21. -

    • Coffee break

  22. -

    • Variations – renewals – extensions (Amy Hughes - Merck Sharp & Dohme Europe)

  23. -

    • Closing remarks (Marc Benijts - Healixia)

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Schedule of Introduction to Regulatory Affairs 2023