21 & 22 November 2013

Venue: Novotel Brussels Airport – Da Vinci laan 25, 1831 Diegem

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. All speakers are experienced tutors from university, FAMHP and industry.

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.

Thursday, 21 November 2013

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
Kristin Mertens

Session 2: Drug Substance

11.30 Drug substance: General requirements
Bernard Pirotte

12.15 Lunch

13.30 Drug substance: Synthesis and control during synthesis
Speaker tbc

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
Sabine Dierickx

17.30 End of the first day

Friday, 22 November 2013

Session 4: Variations

09.00 The actualised EU Variations
Roselien Poppe

09.35 Treatment of chemical-pharmaceutical variations at the FAMHP
Daan Debremaeker & Angéline Liénart

Session 5: Variations - Theoretical & practical
application worked out through several case studies

10.15 Introduction to the cases
Mixed panel FAMHP & Industry

10.30 Coffee break

11.00 Work out of case studies in workshops (1)

12.00 Lunch

13.00 Work out of case studies in workshops (2-3)

15.00 Coffee break

15.15 Work out of case studies in workshops (4)

16.15 Closing discussion on results of workshops
Mixed panel FAMHP & Industry

16.45 Closing remarks
Marc Benijts

17.00 End of the Advan ced Course: CTD Module 3

Presentations will be given in English.

Registration Fees :
€ 900,00 for BRAS members
€ 1.100,00 for non BRAS members
 

Cancellation :
Cancellations will neither be accepted nor reimbursed after 12 November 2013. Before that date 20% will be retained for administrative costs.


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