BRAS Advanced Course CTD module 3 – Quality section
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.
BRAS ADVANCED COURSE
CTD module 3 – Quality section
7th edition November 16-17, 2017
Venue: Novotel Brussels Airport – Leonardo Da Vinci Laan 25, 1831 Diegem
Program and speakers
Section I: General aspects (substance & product)
08.30 Registration and coffee
09.00 Welcome & introduction to the course
Marc Benijts (BRAS)
09.15 Overview CTD – Quality related issues
Katrien Van Landuyt (FAMHP)
09.45 Relevant analytical techniques and method validation
Evelien Wynendaele (Ugent)
10.30 coffee break
11.00 Stability in the Pharmaceutical World
Christel Ooms (Janssen)
Section II: Drug substance
11.45 Drug substance: general requirements
Bernard Pirotte (Ulg)
13.15 Drug substance: synthesis and control during synthesis
Michel Guillaume (Janssen)
14.00 Drug substance: impurities
Sonja Beken (FAMHP) – René Hanselaer (FAMHP)
15.00 coffee break
Section III - Drug product
15.15 Drug products: General overview and practical tips
Isabelle Delneuville (FAMHP)
16.00 Parenteral dosage forms
Sabine Dierickx (Pfizer) TBC
16.45 Solid oral dosage forms
Valérie Vanhoorne (Ugent)
17.30 End of first day
Section IV: Variations
09.00 Variations according to Regulation EC 1234/2008
Roselien Poppe (FAMHP)
09.30 Handling of Variations to Module 3
Daan Debremaeker (FAMHP) & Angéline Lienart (FAMHP)
10.15 Variations – Theoretical & practical application worked out through several case studies Introduction to the cases
Mixed panel FAMHP & Industry: Daan Debremaeker (FAMHP) – Isabelle Delneuville (FAMHP) – Bart Denayer (FAMHP) – Guy Fonck (FAMHP) – Debbie Lettani (Janssen Pharmaceutica) - Ann Matton (Pfizer) – Inge Terryn (Janssen Pharmaceutica) - Rembert Van de Sande (Pfizer) - Katrien Van Landuyt (FAMHP)
10.30 Coffee break
11.00 Work out of case studies in workshops (1)
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
16.35 Closing remarks
16.45 End of course
Registrations through our website. (www.bras-org.be)
For registration you click on the line of the course in “Future courses and events” on the Home Page and then sign up. If you are not yet registered on the website you will be asked to do so. The system will send you a confirmation of registration with payment modalities by return mail.
If you need more assistance please contact Brigitte at email@example.com or call her on 02.757 06 29.
Fees: BRAS member 900€ - Non-BRAS member 1.100€
It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 8 November 2017 or no-show, the fees are due and will be invoiced.
Program and speakers
If you need more assistance, please contact Brigitte Frenay at firstname.lastname@example.org or call her on +32 2 757 06 29.
It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 08/11/2017 or no-show, the fees are due and will be invoiced.
16 November 08:30 » 17 November 17:00
Novotel Brussels Airport – Leonardo Da Vinci Laan 25, 1831 Diegem