Posted by Michael Wonder on 19 Jun 2018
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products
19 June 2018 - The EMA published in July 2017 a guideline for first‐in‐human drug studies.
The purpose of this document is to assist investigators, pharmaceutical companies, ethics committees and other regulators and stakeholders with the design and performance of early clinical studies of new compounds in humans.
The focus of the guideline is on risk mitigation and promotion of safety. The guideline is a revision of an earlier version dated 2007 and extends the existing EU guidance to address first-in-human and early phase clinical trials with integrated protocols.
