FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).
The Clinical Trial Regulation (CTR) 536/2014 will enter into force at the end of January 2022. The aim of this new regulation is administrative simplification and harmonisation within Europe. The new Regulation will harmonise the assessment and supervision processes for clinical trials throughout the European Union, via a Clinical Trials Information System (CTIS). CTIS will consist of the centralised EU portal and the database for clinical trials.
The new Regulation was already approved in 2014, but the full functionality of CTIS had yet to be confirmed through an independent audit. On 21 April 2021, EMA's Management Board confirmed that CTIS meets the functional specifications, following an independent, successful audit. CTIS will go live on 31 January 2022.
Practical information
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.
A detailed agenda will follow soon. Registration for the information sessions will be possible later this month.