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Search results with tag "No 536"
Guideline for the notification of serious breaches of ...
www.ema.europa.eu311 January 2017 2 . EMA/430909/2016 3 . Guideline for the notification of serious breaches of . 4 . Regulation (EU) No 536/2014 or the clinical trial protocol
Guideline on GCP compliance in relation to trial …
www.ema.europa.eu72 1. Executive summary 73 This guideline has been prepared to assist sponsors and investigators to comply wih the requirements t 74 of the Clinical Trials Regulation EU) No 536/2014( (referred to as the Regulation“ ”) on clinical trials on