The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now showing up in CTIS. Nevertheless, planning ahead for a successful submission and knowing what to expect from the new system can be a challenge.
In this session, our experts answered questions related to the changes made and points to be noted, such as:
- Are you wondering when you should transition your ongoing trial to the EU CTR?
- Whether you can switch from the trial-centric approach to the organization-centric approach?
- How and to whom to submit your safety reports under the EU CTR?