How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? Where do we currently stand with the implementation in different Member States
A revision of the Clinical Trials Regulation has been adopted by European legislation makers in 2014. This revised legal framework will bring significant advances compared to todays’ situation and is expected to be fully implemented as soon as the supporting Clinical Trials Portal and Database are fully functional (2H2017).
The opportunity of the new Regulation to improve harmonisation and competitiveness of clinical research in Europe while safeguarding patients interests must be fully carried through at the national level to enable our region to emerge as an attractive place for conducting Clinical Research. This will not only benefit commercial and non-commercial sponsors, but specifically patients who are eagerly waiting to participate in Clinical Trials and benefit from new treatment options. The new legal rules specifically mandate a closer co-ordination of clinical trial applications assessments across EU Member States, supported by much closer collaboration between the national competent authorities and the ethics committees within each Member State.
More information on the workshop website.