EIPG feedback on draft guideline for notification of serious breaches in clinical trials

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The European Medicines Agency recently launched a public consultation on a draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.

Read the EIPG Feedback on the draft guideline.

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