An EU4Health Joint action for expedited assessment of multinational COVID19 trials will start from February 2022. In order to provide potential developers and clinical trial sponsors with information about this joint action, the coordinators and the steering committee has organised an info session to stakeholders, which will take place on 3 February from 10:00 to 12:00 CET (see attached programme). Please note that the scope is limited to COVID19 therapeutic trials submitted under the Clinical Trials Regulation ((EU) 536/2014). The deadline for registration is 31 January 2022.
FAMHP organises two information sessions to provide all sponsors and applicants for clinical trials with as much information as possible about the new Regulation.
The first information session will take place virtually on 23 September 2021. During this session, an update will be given on the different aspects of the CTR implementation in Belgium and on the current status of the CTR pilot project.
A second information session will be organised on 25 November 2021 with the aim of sharing a more practical and national demo. The demo strongly depends on the availability of the "sandbox", an isolated virtual environment where CTIS can be tested without disrupting its further operation and development.