The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements
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Clinical trials – Regulation EU No 536/2014
Published by European Commission (EC)
RegulationClinical TrialsGood Clinical Practice (GCP)Good Manufacturing PracticeThe inspection of clinical trials may concern good clinical practice as regards the conduct of clinical trials as well as good manufacturing practices as regards the manufacturing of the investigational medicinal products.
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