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

Clinical Trials Toolkit

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

View this resource Bookmark this resource