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HRA response to the European Medicines Agency Concept paper on the revision of the Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

Published on 3 October 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), has recently consulted on a concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’.

The concept paper sets out proposed changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. Our response to this consultation can be found here

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