Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Published by European Medicines Agency (EMA)ECRIN

The guideline is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs). The document includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and on the conduct of FIH/early CTs

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Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

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