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

Day 1
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)

12.30 Lunch

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
 

Day 2
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)

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

16.35 Closing remarks
Marc Benijts

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 bras@bras-org.be 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

Download program

If you need more assistance, please contact Brigitte Frenay at bras@bras-org.be 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.

Event info

16 November 08:30 » 17 November 17:00

Location
Novotel Brussels Airport – Leonardo Da Vinci Laan 25, 1831 Diegem

Language
English

Member price
€ 900.00

Non-member price
€ 1100.00
Sign up