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?
|
Topic |
Speaker | Duration in minutes |
| General state of play at EU and NL level |
Greet Musch (Director-General PRE authorisation, FAMHP) |
15 |
| 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 |
45 |
|
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) |
30 |
| Q&A: panel discussion |
|
15 |
| 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 CTRpilot@fagg-afmps.be no later than 16 September 2021.