Article

Adapting to new clinical trial regulation in EU

By: Olga Björklund and Dr Brian Edwards, Principal Consultant

Publ. 2016-02-19

With the EU Clinical Trial Regulation coming into effect by October 2018 at the latest, sponsors should start
preparing for the new legislative framework to maximise positive efficiencies and minimise any burdens

The new Clinical Trial Regulation (EU) No 536/2014 was adopted on 16 April 2014 and published in the Official Journal on 27 May 2014. When it comes into full effect, it will bring a revised set of rules for the conduct of clinical trials in Europe with a focus on modernisation, streamlined processes and increased public access to information. Unsurprisingly, the interest of the research community is high and it is hoped that the new environment will boost conduct of clinical trials in the EU. Aimed at pharmaceutical industry sponsors, updates about the implementation are discussed together with some advice to help prepare more efficiently for this new regulatory framework.

Article originally published on pages 14-18 in February 2016 issue of International Clinical Trials (ICT),  © Samedan Ltd . ICT is a specialist journal designed to provide global coverage of key topics pertinent to the clinical trials sector.

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The Authors

Dr Brian Edwards,
Principal Consultant

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Olga Björklund

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