Advanced Course CTD module 3 - Quality section 2022

Thursday, May 12, 2022 from 8:30 AM to 5:45 PM, Friday, May 13, 2022 from 9:00 AM to 5:00 PM Regulatory Affairs

Schedule of Advanced Course CTD module 3 - Quality section 2021

Day 1, Thursday, May 12
8:30 - 9:00 Registration & coffee
9:00 - 9:15 Welcome & Introduction to the course (Marc Benijts - Healixia)
9:15 - 9:45 Overview CTD – Quality related issues (Katrien Van Landuyt - FAMHP)
9:45 - 10:30 Relevant analytical techniques and method validation (Evelien Wynendaele - Ugent)
10:30 - 11:00 Coffee break
11:00 - 11:45 Stability in the Pharmaceutical World (Geert Van Nyen - Janssen Pharmaceutica)
11:45 - 12:30 Drug substance: general requirements (Thomas Drapier, FAMHP)
12:30 - 13:15 Lunch break
13:15 - 14:00 Drug substance: synthesis and control during synthesis (Michel Guillaume, Janssen)
14:00 - 15:15 Drug substance: impurities (Non-clinical aspects: Sonja Beken & Evelyne Pirotte - FAMHP; Quality aspects: Bart Denayer, FAMHP)
15:15 - 15:30 Coffee break
15:30 - 16:15 Drug products: General overview and practical tips (Helene Van de Ven - FAMHP)
16:15 - 17:00 Parenteral dosage forms (Roland Schots - Roval Pharma)
17:00 - 17:45 Solid oral dosage forms (Valérie Vanhoorne - UGent)
Day 2, Friday, May 13
9:00 - 9:30 Variations according to Regulation EC 1234/2008 (Roselien Poppe - FAMHP)
9:30 - 10:15 Handling of Variations to Module 3 (Eline Van der Biest & Liesbeth Bogaert - FAMHP)
10:15 - 10:30 Variations: Theoretical & practical application worked out through several case studies - Introduction to the cases (Mixed panel FAMHP & Industry)
10:30 - 11:00 Coffee break
11:00 - 12:30 Work out of case studies in workshops (1) (Mixed panel FAMHP & Industry)
12:30 - 13:30 Lunch break
13:30 - 15:00 Work out of case studies in workshops (2) (Mixed panel FAMHP & Industry)
15:00 - 15:15 Coffee break
15:15 - 16:45 Work out of case studies in workshops (3) (Mixed panel FAMHP & Industry)
16:45 - 17:00 Closing Remarks (Marc Benijts - Healixia)

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