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EFGCP Multi-Stakeholder Workshop & Discussion on

How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? Where do we currently stand with the implementation in different Member States

13 April 2016, MCE Conference Centre, Brussels, Belgium

Organised by EFGCP with the partnership of EATG, ECRIN and EORTC

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 todaysí 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.

EFGCP had hosted an initial workshop in September 2014 to discuss key implementation aspects with patients, academia, ethics committees, regulators and industry and share some good ideas and best practices to swiftly start the process in each country.

This follow-on workshop aims now to show case the tremendous progress that has been made with the implementation over the past 18 months.

The European Commission, for example, is facilitating discussions to resolve some key harmonisation questions across Europe. The EMA has made significant progress with the development of the new EU Clinical Trials Database and Portal which is the key working tool to facilitate a streamlined and swift coordination process between the various parties involved. In addition, Member States have started to develop new local procedures and initiated some early pilots to test the new assessment scenario.

And finally Ethics Committees are intensifying or starting up new collaborations across countries to discuss important aspects of harmonisation of assessment criteria, methodologies and training of reviewers.

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