Ready to equip yourself with first-hand information from our experts? Join us in our new free webinar, “Clinical Trials transition to CTR/CTIS”.
All ongoing clinical trials in the EU must be transitioned to CTIS if they are expected to continue beyond 30 January 2025. Sponsors must consider the time required for Member States to complete the authorisation procedure, which can take up to three months.
To help streamline the process, Member States will implement, where possible and up to 16 October 2024, an expedited procedure for transitioning trials to the CTR. For submission beyond that date, a prompt approval cannot be guaranteed.
As we are now approaching the second half of the final year of transition, it is crucial for sponsors to plan and submit the transition application as soon as possible, to ensure a timely approval and to prevent the potential cessation of trials that do not conform to the new regulation.
Join Asphalion expert Nuria Garcia, our Regulatory Affairs Senior Consultant, as she will goes over:
- Transition timelines and procedures
- How to prepare a transition application
- Management of Post-transition actions
Register here for the webinar: CLINICAL TRIALS TRANSITION TO CTR/CTIS
For further information you can contact us at: [email protected]
