Revised FIH EMA Guideline: Disruptive or Constructive?

The revised 'EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products‘ has been published on 20 July 2017 and came into operation on 01 February 2018. Accordingly, all stakeholders have gathered first experiences with implementation of the required changes. To collect structured information on these first experiences and any difficulties arising from the updated recommendations on early phase clinical trials, EUFEMED has conducted a survey among stakeholders involved in early medicines development, taking up an initiative from the French Club Phase I. The results will be presented and discussed with Competent Authority Representatives from EUFEMED countries / EMA as well as with Sponsors, Investigators, and CROs. Areas of success and fields for further improvement will be identified and resolution of open questions will be sought.


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