Revised guideline on first-in-human clinical trials (FIH CTs) (Part II)
- 30 July 2017
- early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, risk mitigation,
On 25 July 2017, the European Medicines Agency (EMA) published revised version of Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This revised document will become effective on 1 February 2018. We have already informed on our website about a draft of the revised guideline