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Introduction to Regulatory Affairs 2026

The program proposes an introduction to the legal, scientific, organisational and administrative aspects of medical products given by experienced tutors from university, FAMHP and industry.

  1. Day 1, Monday, November 16

  2. -

    • Registration and coffee

  3. -

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

  4. -

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

  5. -

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

  6. -

    • Coffee break

  7. -

    • The pharmaceutical legislation (EU – B) by Zoé Bertrand (Covington & Burling LLP)

  8. -

    • Lunch break

  9. -

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

  10. -

    • Coffee break

  11. -

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

  12. -

    • Pharmacovigilance by Begüm Benli Peker & Aline Poliart (BMS)

  13. Day 2, Tuesday, November 17

  14. -

    • Registration and coffee

  15. -

    • Legislation for clinical trials - Jeroen De Roeck (FAMHP)

  16. -

    • Coffee break

  17. -

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

  18. -

    • CTD module 5 by Nele Berthels (FAMHP)

  19. -

    • Lunch break

  20. -

    • CTD module 4 by TBC (FAMHP)

  21. -

    • CTD module 3 by Evelien Wynendaele (UGent)

  22. -

    • Coffee break

  23. -

    • Variations – renewals – extensions by TBC (MSD)

  24. -

    • Closing remarks by Marc Benijts (HEALIXIA)

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Schedule of Introduction to Regulatory Affairs 2026