January 2023: Belgium Registry Update

Title: January 2023: New Clinical Trial Regulation Information Sessions for Sponsors

The ‘News FAMHP’ announced an update on January 09, 2023, that two general sessions on the Clinical Trials Regulation will take place in the FAMHP building on March 10th and 13th, 2023, open to all sponsors.

The session scheduled for March 10, 2023, will cover the experiences of national competent authorities (NCAs), ethics committees, and sponsors in the first year of CTR implementation. Attendees will receive regulatory information, learn about European initiatives and working groups, and focus on collaboration with academics. The session will conclude with a Q&A round.

The second session, which will take place on March 13, 2023 (in the morning), will concentrate on early-phase clinical trials in CTR and go through the key considerations and best practices for raising the predictability of applications and lowering the number of evaluation questions.

Sponsors interested in attending must send an email to [email protected] by February 15, 2023, with the subject “registration CTR info session 2023”. Sponsors have the option to register for one or both sessions. Due to limited seating, only two members per sponsor can attend. A pdf of the sessions will be provided afterward. Sponsors may also send any questions in advance to [email protected] by January 31, 2023, with the subject “Q&A CTR info session 2023”.

For more information, please click here.