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May 27, 2014 was a pivotal day for clinical trials in the European Union (EU). On this date, the EU Clinical Trial Regulation (No. 536/2014) was officially published, replacing EU directive No. 2001/20/EC and revamping the way clinical trials are conducted in the region. For international trial sponsors as well as National Competent Authorities and EU member states, this regulation is a game-changer.
The new regulation harmonizes clinical trial requirements throughout the EU by establishing a new Clinical Trials Information System—a centralized portal and database developed and maintained by the European Medicines Agency (EMA) in collaboration with the European Commission and EU member states. Part of the information system will be open to the public subject to new transparency rules.
Find out more about our Life Sciences Services.
In our new whitepaper, we examine the upcoming regulation's impact on the clinical trial process for trial sponsors around the globe.
In this paper, you'll learn:
Ready to learn more? Download the paper today.