Second information session on the new Clinical Trial Regulation (CTR) on 15 December 2021

date: 08/12/2021

The FAMHP is organising the second information session on the new Clinical Trial Regulation (CTR) for sponsors and applicants of clinical trials on 15 December 2021 from 9 a.m. to 12 noon. The presentation and questions and answers of the first info session are now available.

The presentations will be held in English and participation is free.

Provisional programme of the second information session:

Topic

Speaker Duration in minutes

Introduction

Greet Musch (Director-General PRE authorisation, FAMHP)  10
Summary of the questions and answers of the first CTR information session on 23 September 2021

Anne Lenaers (national contact point CTR, FAMHP)
Katelijne Anciaux (CT-College)

15
Advantages of the early transition of the clinical trials from directive to regulation? Anne Lenaers (FAMHP) 10
Q&A: panel discussion   20

Break

  10
Clinical Trials Information System (CTIS): state of play Hans Vincke (FAMHP) 15
European Medicines Agency (EMA) strategy to prepare future users of CTIS, including academic sponsors Anne Lenaers (FAMHP) 10

Sandbox: preparation of CTR implementation

  • at FAMHP
  • at Clinical Trials College (CT-College) and for the Ethics Committees
Hans Vincke (FAMHP) 
Julien Frgacic (CT-College)

15

Q&A: panel discussion    20
Closure of the session Greet Musch (Director-General PRE authorisation, FAMHP) 10


Participation
If you would like to participate in the CTR info session on 15 December 2021 from 9 a.m. to 12 noon, please send an email with the participant's name and email address to CTR@fagg-afmps.be, no later than 13 December 2021.
Before the info session, each participant will receive an email with a link to participate.

Presentation first info session
During the first CTR info session, an update was given on the various aspects of the CTR implementation in Belgium, as well as a current status of the CTR pilot project.
The presentation of that first info session is now available on our website.

The Q&A document on the first info session is also available.

Last updated on 08/12/2021