29 & 30 November 2010

2 days Advanced Course: CTD Module 3

Location: Sheraton Rogier

Fees: BRAS member 900€ / Non-member 1.100€

Only 30 seats available - Please register online

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.

Monday, 29 November 2010

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 validation method
Bart De Spiegeleer

10.30 Coffee break

10.45 Stability issues in the Pharmaceutical World
Joeri De Rijck

Session 2: Drug Substance

11.30 Drug substance: General requirements
Bernard Pirotte

12.15 Lunch

13.30 Drug substance: Synthesis and control during synthesis
Koen Iterbeke

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
Martine Draguet

16.45 Parenteral dosage forms
Sabine Dierickx

17.30 End of the first day

Tuesday, 30 November 2010

Session 4: Variations

09.00 The actualised EU Variations
Iris Geussens

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

10.30 Coffee break

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

12.15 Lunch

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

14.00 Work out of case studies in workshops

15.00 Coffee break

15.15 Presentation of workshops results & discussion
FAMHP & Industry

17.00 Closing remarks
Marc Benijts

17.15 End of the Advanced Course: CTD Module 3

The language for the Advanced Course: CTD module 3 is English.
No simultaneous translation available.