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Risk Mitigation European Union European Medicines Agency (EMA)

Hogan Lovells

The EMA intends to update the Guidance concerning Additional Risk Minimisation Measures

Hogan Lovells on

The European Medicines Agency (“EMA”) has announced its intention to update the Agency’s existing guidance concerning additional risk minimisation measures (“aRMMs”). The revised version will provide extensive guidance on...more

Hogan Lovells

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

Hogan Lovells on

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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