News & Analysis as of September 18, 2024

European Union

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EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

Hogan Lovells on 7/28/2017

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more

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Risk Mitigation › Clinical Trials › European Union

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

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