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

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.