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Transitional Trials: dedicated workshop and updated CTCG guidance

In collaboration with the Member States and the European Commission, EMA held a Workshop on 5 July 2023 on the joint actions for transitioning ongoing trials to the Clinical Trials Regulation.

date:  13/07/2023

The half-day workshop included presentations by sponsor representatives on the estimated number of ongoing trials that would need to be transitioned, with discussion of foreseen and existing challenges. Following dedicated break-out sessions, participants proposed solutions to ease and facilitate the transition of ongoing trials.

The CTCG has already published their revised best practice guide for sponsors and a related Annex which provides a template cover letter for applications transitioning a clinical trial to the CTR.

The EudraLex Q&A will be updated in due course.