First information session on the new Clinical Trial Regulation (CTR) on 23 September 2021

date: 16/07/2021

The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021 for sponsors and applicants of clinical trials about the new Clinical Trial Regulation (CTR). The first information session will take place virtually on 23 September 2021 from 9 a.m. to 12:30 p.m.

The provisional programme of the first information session:

CTR preparedness: are we ready?


Speaker Duration in minutes
General state of play at EU and NL level

Greet Musch (Director-General PRE authorisation, FAMHP)

Overview of four years CTR pilots Anne Lenaers (National Contact Point CTR, FAMHP) 30
Lessons learnt from the CTR pilot project: points of concern experienced in submissions

FAMHP – speakers to be confirmed

CT-College, Ethics Committees – speakers to be confirmed


Experiences from the CTR pilots and VHP Plus procedures

Commercial sponsors – speakers to be confirmed

Academic sponsors – Ann Vankerkom (Clinical Trial Center UZ Leuven) and Frédéric Henot (Regulatory Affairs Manager, Institut Jules Bordet)

Q&A: panel discussion


Break   15
Substantial modifications Speakers to be confirmed 15
Transition: to switch or not to switch? Marleen Laloup (Head of Division Research and Development a.i., FAMHP) 15
CTIS: state of play and training Hans Vincke (FAGG) and Julien Frgacic (CT-College) 15
Future strategy: points of interest Greet Musch (Director-General PRE authorisation, FAMHP) 15

The presentations will be in English.
If you would like to participate in the CTR info session on 23 September 2021 from 9 a.m. to 12.30 p.m., please send an email with the participant's name and e-mail address to no later than 16 September 2021.

Last updated on 16/07/2021