Advanced Course CTD Mod 5


1th edition

February 23-24, 2015

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 Clinical 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. 

Programme and speakers

Day 1

09.00 Registration and coffee

09.30 Welcome and opening remarks
                Marc Benijts (BRAS)

09.45 Clinical aspects of the CTD: Theoretical overview and practical considerations
                Miranda Vroenhove (FAMHP)

10.30 Coffee Break

11.00 Patient safety in hospitals and the importance of Evidence Based Practice
                 Dominique Vandijck (Ugent – Hasselt University)

11.45 EBM – Efficacy and Safety applications: case studies
                Stefan Bonné (FAMHP)

12.30 Lunch

13.30 Bioequivalence: basics and applications. Scientific guidelines on the investigation of bioequivalence. Practical approach and common errors
                Joëlle Warlin (FAMHP) & Marleen Laloup (FAMHP)

14.30 Core principles and challenges of global clinical drug development
                Inge Lefèvre (GSK) 

15.15 Coffee Break 

15.45 Statistics in clinical trials: principles, practice and pragmatism
                 Geert Molenberghs (KUL) 

16.30 A practical approach of GCP in the guidelines and inspections
                  Dominique Delforge (FAMHP)

17.15 End of day 1 

Day 2

09.30 Benefit-Risk Assessment
                 Diederica Claeys (FAMHP)

10.30 Coffee Break

11.00 Safety issues related to QT prolongation and interactions: implications for the SmPC
                 Nele Steens (FAMHP) & Bruno De Schuiteneer (FAMHP)

12.00 Design modalities of clinical trials across drug development
                 Paul Stoppie (FAMHP) & Olga Kholmanskikh Van Criekingen (FAMHP)

12.45 Lunch 

14.00 Clinical investigation for paediatric population
                 Jacqueline Carleer (FAMHP)

15.00 Coffee Break 

15.30 Drug use in older people: pharmacology and availability and applicability of information on rational prescribing
                  Mirko Petrovic (Ugent)

16.30 Closing remarks
                  Marc Benijts (BRAS)

16.45 End of course


Presentations will be given in English (exception possible at the request of the speaker).

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

Further practical information can be obtained through BRAS Administrative Office, Mrs. Brigitte Frenay tel +32 2 757 06 29 or

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 13 February 2015, the fees are due and will be invoiced.