| 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)
|
