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EFGCP Multi-Stakholder Workshop and Discussion on

How to Ensure Optimal Ethical Review Within the New Clinical Trial Regulation?

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 inEuropewhile 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 eachMemberState.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.


13 Apr 2016 @ 09:00 am

13 Apr 2016 @ 05:00 pm

Duration: 8 hours


Management Center Europe

Rue de l'Aqueduc 118




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Sandeep Menon
Vice President & Head of Early Clinical Dev., Biostatistics & Adjunct Assistant Professor


Frederick J. Wenzel
Even Organizer


Sean Mccarthy
Managing Director


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