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20.05.2015 08:31 Age: 9 yrs

Clinical Studies

new EU Regulation

Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products ("IMPs").

On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC(875 KB) was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation“).

Guidelines, publications and more >> here