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.
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Day 1, Monday, December 11
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8:30 - 9:00
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Registration and coffee
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9:00 - 9:15
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Welcome & introduction to the course (Marc Benijts - Healixia)
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9:15 - 10:15
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Pharmaceuticals – definitions – product life cycle - (Sofie Starckx - Janssen Research & Development)
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10:15 - 11:15
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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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11:15 - 11:45
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Coffee break
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11:45 - 12:45
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The pharmaceutical legislation (EU – B) (Peter Bogaert & Bart Van Vooren - Covington & Burling LLP)
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12:45 - 13:45
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Lunch
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13:45 - 14:45
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European Medicines Agency – EU procedures for Marketing Authorizations - part 1 (Ingrid Theeuwes - PhaRA consulting)
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14:45 - 15:00
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Coffee break
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15:00 - 15:45
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European Medicines Agency – EU procedures for Marketing Authorizations - part 2 (Ingrid Theeuwes - PhaRA consulting)
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15:45 - 17:00
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Pharmacovigilance (Aline Poliart – Bristol Myers Squibb)
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Day 2, Tuesday, December 12
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9:00 - 10:15
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Legislation for clinical trials (Anne Lenaers - FAMHP)
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10:15 - 10:30
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Coffee break
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10:30 - 11:30
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CTD module 3 (Evelien Wynendaele - UGent)
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11:30 - 12:30
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CTD module 4 (Gaëlle De Meyer - FAMHP)
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12:30 - 13:15
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Lunch
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13:15 - 14:30
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CTD module 5 (Nele Berthels - FAMHP)
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14:30 - 15:45
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Marketing Authorization – Legal basis – Practical aspects linked to module 1 (Karolina Szlufcik & Machteld Verbruggen - FAMHP)
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15:45 - 16:00
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Coffee break
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16:00 - 17:30
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Variations – renewals – extensions (Amy Hughes - Merck Sharp & Dohme Europe)
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17:30 - 17:45
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Closing remarks (Marc Benijts - Healixia)
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