20-21 November 2008

Sheraton Brussels Airport

Programme:

Thursday, 20 November 2008

09.00 Welcome & Opening remarks
Marc Benijts

General (product & drug)

09.15 Overview CTD - Quality related issues
Wim Penninckx

09.45 Relevant analytical techniques and validation method
Bart De Spiegeleer

10.30 Coffee break

10.45 Stability in the Pharmaceutical World
Richard Klep

Drug Substance

11.30 Drug substance: General requirements
Bernard Pirotte


12.15 Lunch


14.00 Drug substance: Synthesis and contraol during synthesis
Ivan Somers

14.45 Drug substance: Impurities
S. Beken & Marie-Jo?lle De Vos

15.30 Coffee break

Drug Product

15.45 General overview and practical tips
Katrien Van Landuyt

16.30 Parenteral dosage forms
Speaker tbc

17.15 Solid oral dosage forms
Brigitte Everard

18.00 End of the first day



Friday, 21 November 2008

Variations

09.00 The revised version of the EU Variations
Vanessa Binam?

09.45 Treatment of chemical-pharmaceutical
variations at the FAMHP
Daan Debremaeker

10.30 Coffee break

10.45 Case 1 : submission of a valid IB variation (presentation & work out in group)
Sofie Termont


12.15 Lunch


14.00 Variations Type II Theoretical application worked out through several case studies

14.30 Work out of Case studies in workshops

15.30 Coffee break

15.45 Presentation of workshops results & discussion
Liesbeth Bogaert, Isabelle Delneuville,
Bart Denaeyer, Guy Fonck (FAMHP)
&
Dominique Eycken, Hilde Vanneste (J&J)

17.30 Closing remarks
Marc Benijts

17.40 End of the Advanced Course: CTD Module 3