Advanced Course CTD module 3 - Quality section 2022
This two-day course is intended to provide an in depth knowledge and understanding of the main principles and concepts of the Quality part of the Common Technical Document.
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Day 1, Thursday, May 12
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Registration & coffee
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Welcome & Introduction to the course (Marc Benijts - Healixia)
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Overview CTD – Quality related issues (Katrien Van Landuyt - FAMHP)
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Relevant analytical techniques and method validation (Evelien Wynendaele - Ugent)
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Coffee break
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Stability in the Pharmaceutical World (Geert Van Nyen - Janssen Pharmaceutica)
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Drug substance: general requirements (Thomas Drapier, FAMHP)
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Lunch break
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Drug substance: synthesis and control during synthesis (Michel Guillaume, Janssen)
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Drug substance: impurities (Non-clinical aspects: Sonja Beken & Evelyne Pirotte - FAMHP; Quality aspects: Bart Denayer, FAMHP)
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Coffee break
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Drug products: General overview and practical tips (Helene Van de Ven - FAMHP)
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Parenteral dosage forms (Roland Schots - Roval Pharma)
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Solid oral dosage forms (Valérie Vanhoorne - UGent)
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Day 2, Friday, May 13
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Variations according to Regulation EC 1234/2008 (Roselien Poppe - FAMHP)
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Handling of Variations to Module 3 (Eline Van der Biest & Liesbeth Bogaert - FAMHP)
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Variations: Theoretical & practical application worked out through several case studies - Introduction to the cases (Mixed panel FAMHP & Industry)
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Coffee break
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Work out of case studies in workshops (1) (Mixed panel FAMHP & Industry)
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Lunch break
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Work out of case studies in workshops (2) (Mixed panel FAMHP & Industry)
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Coffee break
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Work out of case studies in workshops (3) (Mixed panel FAMHP & Industry)
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Closing Remarks (Marc Benijts - Healixia)
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