Clinical Trials Workshop I Translating the New Clinical Trials Regulation into Practice

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures, panel discussions, and interactive break-out sessions.

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.

Day 1 will focus on the new provisions for submission, assessment and decision-making of clinical trial applications, and the management and monitoring of trials. Day 2 will focus on the new transparency provisions for clinical trials.