Guideline on Strategies to Identify and Mitigate Risks for ...
assemble information relevant to the safety of first-in-human clinical trials must be science-based, and should be made and justified on a case-by-case basis. Quality aspects should not, in themselves, be a source of risk for first-in-human trials. Nevertheless,
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www.ema.europa.euThis is the first revision of the ‘ Guideline on strategies to identify and mitigate risks for first -in-human clinical trials with investigational medicinal products ’. It extends the existing EU guidance to address first-in-human (FIH) and early phase clinical trials ( …
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