From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.
In December 2021, the Clinical Trial Regulation 536/2014 will enter into force. The aim of this important change in legislation is administrative simplification and harmonisation within Europe. In cooperation with the College responsible for designating the ethical committee for the evaluation of a clinical trial, the ethics committees and the sponsors of clinical trials, the FAMHP has been running the CTR pilot project since 2017.
The CTR pilot project is an ideal way to anticipate the transition to the new regulation. Over the course of the past few years, the CTR pilot project has had increasing success with the sponsors. Therefore, we would like to thank all the participants who, together with the FAMHP, have enthusiastically participated in preparing the implementation of the CTR. This pilot project will continue until the European portal is available and the CTR comes into force.
The current COVID-19 pandemic has a significant impact on the FAMHP's available capacity to process clinical trial dossiers. We are therefore forced to temporarily limit the number of initial pilot dossiers we can accept each week. From mid-February 2021, a reservation system with time slots will be used for submitting initial dossiers for the CTR pilot project.
If applicants have not found a time slot for their initial submission on the desired date and cannot postpone it, they will be given the option to use a "hybrid" alternative. This is linked to filing a dossier under the law of 7 May 2004.
Participate in the webinar on 4 February 2021
The new procedure with time slots for the CTR pilot project will be explained during a webinar on 4 February 2021 at 2 PM. Registration is possible at the latest on 2 February 2021 by sending an e-mail with your name and e-mail address to CTRpilot@fagg-afmps.be.
In order to give all sponsors/applicants the opportunity to participate, we ask you to limit yourself to one participant per sponsor/company.