Clinical Trials Workshop
Are we ready for implementation of the new Clinical Trials Regulation?

The new EU Clinical Trials Regulation is expected to become applicable in 2016. The new legislation will have implications on clinical trial sponsors preparing and submitting clinical trial applications. Member States will have to adapt their procedures for the assessment of clinical trial applications by competent authorities and review by ethics committees. Additionally, the new Regulation will impact how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU Clinical Trials Database will enforce disclosure of clinical trials data and information.

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.There will be a particular focus on the critical issues affecting sponsors and Member States as they consider the impact and changes needed to implement the Regulation.