Introduction to Regulatory Affairs 2022
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, Thursday, November 17
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Registration and coffee
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Welcome & introduction to the course (Marc Benijts - Healixia)
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Pharmaceuticals – definitions – product life cycle - (Lieve Lammens - Janssen Research and Development)
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The European Union and its institutions – The Belgian bodies (Peter Bogaert & Bart Van Vooren (Covington & Burling LLP)
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Coffee break
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The pharmaceutical legislation (EU – B) (Peter Bogaert & Bart Van Vooren - Covington & Burling LLP)
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Lunch
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European Medicines Agency – EU procedures for Marketing Authorizations - part 1 (Ingrid Theeuwes & Frank Vandendriessche - PhaRA consulting)
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Coffee break
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European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (Ingrid Theeuwes & Frank Vandendriessche - PhaRA consulting)
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Pharmacovigilance (Aline Poliart – Bristol Myers Squibb)
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Day 2, Friday, November 18
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Legislation for clinical trials (Anne Lenaers - FAMHP)
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Coffee break
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CTD module 3 (Evelien Wynendaele - UGent)
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CTD module 4 (Gaëlle De Meyer - FAMHP)
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Lunch
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CTD module 5 (Nele Berthels - FAMHP)
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Variations – renewals – extensions (Sofie Langereis - Merck Sharp & Dohme Europe)
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Coffee break
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Marketing Authorization – Legal basis – Practical aspects linked to module 1 (Nicolas Nyssen & Machteld Verbruggen - FAMHP)
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Closing remarks (Marc Benijts - Healixia)
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