Introduction to Regulatory Affairs 2025
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.
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Day 1, Monday, December 1
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Registration and coffee
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Welcome & introduction to the course by Marc Benijts (HEALIXIA)
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Pharmaceuticals – definitions – product life cycle by Sofie Starckx (Johnson & Johnson Innovative Medicine)
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The European Union and its institutions – The Belgian bodies by Peter Bogaert & Spiros Drosos (Covington & Burling LLP)
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Coffee break
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The pharmaceutical legislation (EU – B) by Peter Bogaert & Zoé Bertrand (Covington & Burling LLP)
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Lunch break
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European Medicines Agency – EU procedures for Marketing Authorizations - part 1 by An Van Hemelrijck (PhaRA consulting)
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Coffee break
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European Medicines Agency – EU procedures for Marketing Authorizations - part 2 by An Van Hemelrijck (PhaRA consulting)
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Pharmacovigilance by Begum Benli Peker & Aline Poliart (BMS)
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Day 2, Tuesday, December 2
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Registration and coffee
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Legislation for clinical trials - Jeroen De Roeck (FAMHP)
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Coffee break
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Marketing Authorization – Legal basis – Practical aspects linked to module 1 by Karolina Szlufcik (FAMHP)
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CTD module 5 by Nele Berthels (FAMHP)
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Lunch break
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CTD module 4 by Gaëlle De Meyer (FAMHP)
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CTD module 3 by Evelien Wynendaele (UGent)
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Coffee break
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Variations – renewals – extensions by Jeroen de Wilt (MSD B.V., The Netherlands)
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Closing remarks by Marc Benijts (HEALIXIA)
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