Advanced Course: CTD Mod 3
8 & 9 December 2011
Location: Sheraton Rogier
 

Thursday, 8 December 2011

09.00 Welcome & Opening remarks
Marc Benijts

Session 1: General (product & drug)

09.15 Overview CTD - Quality related issues
Katrien Van Landuyt

09.45 Relevant analytical techniques and method validation
Bart De Spiegeleer

10.30 Coffee break

10.45 Stability issues in the Pharmaceutical World
Nele Uytterhoeven

Session 2: Drug Substance

11.30 Drug substance: General requirements
Bernard Pirotte

12.15 Lunch

13.30 Drug substance: Synthesis and control during synthesis
Roselien Poppe

14.15 Drug substance: Impurities
Sonja Beken & Nathalie Parij

15.00 Coffee break

Session 3: Drug Product

15.15 General overview and practical tips
Isabelle Delneuville

16.00 Solid oral dosage forms
Brigitte Evrard

16.45 Parenteral dosage forms
Speaker tbc

17.30 End of the first day

Friday, 9 December 2011

Session 4: Variations

09.00 The actualised EU Variations
Speaker tbc

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

10.40 Coffee break

11.00 Variations Type II theoretical & practical application worked out through several case studies
Mixed panel FAMHP & Industry

12.00 Lunch

13.30 Variations Type II theoretical & practical application worked out through several case studies
(Work out of case studies in workshops)
Mixed panel FAMHP & Industry

15.30 Coffee break

15.45 Presentation of workshops results & discussion
FAMHP & Industry

17.00 Closing remarks
Marc Benijts

17.15 End of the Advanced Course: CTD Module 3