Two days course: 03-04 December 2009

Location: Sheraton Brussels Rogier

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.

The course is designed for the experienced Regulatory Affairs Manager who requires a compact and comprehensive actualisation on the subject.

Upon completion of this course, attendees will have a refreshment of the basic scientific concepts as well as a clear understanding of the practical industrial challenges and the point of view of the Belgian experts.
They will have gained the basic background knowledge necessary to ensure an optimal management and follow up of a dossier.

Programme:
- Day 1
09.00 Welcome & Opening remarks – Marc Benijts

Session 1: General (product & drug)
09.15 Overview CTD – quality related issues - Katrien Van Landuyt (FAMHP)
09.45 Relevant analytical techniques and method validation – Prof. Dr. Bart De Spiegeleer (Ugent)

10.30 Coffee break

10.45 Stability issues – Speaker t.b.c.

Session 2: Drug Substance
11.30 General requirements for drug substance – Prof. Dr. Bernard Pirotte (Ulg)

12.15 Lunch

14.00 Synthesis and control during synthesis for drug substances – Ivan Somers (J&J)
14.45 Impurities – Sonja Beken (FAMHP) – Nathalie Parij (FAMHP)

15.30 Coffee break

Session 3: Drug Product
15.45 General overview and practical tips on drug products – Isabelle Delneuville (FAMHP)
16.30 Specific issues with parental dosage forms – Sabine Dierickx (Pfizer)
17.15 Solid oral dosage forms – Prof. Dr. Brigitte Evrard (Ulg)
18.00 End of the first day

- Day 2
Session 4: Variations
09.00 The revised version of the EU variations – Iris Geussens (FAMHP)
09.45 Treatment of chemical-pharmaceutical variations at FAMHP – Daan Debremaeker (FAMHP)

10.30 Coffee break

10.45 Introduction to case studies on variations – mixed panel FAMHP & Industry

12.00 Lunch

14.00 Work out of case studies in workshops
15.30 Coffee break
15.45 Presentation of workshop results & discussion
17.30 Closing remarks – Marc Benijts
17.45 End of the course

Language: English. No simultanious translation available

Be aware that the course is intended for a LIMITED NUMBER OF PARTICIPANTS ensuring an optimal learning process