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Risk Mitigation Clinical Trials New Guidance

Hogan Lovells

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

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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

Hogan Lovells

The MHRA issues new guidance concerning common issues in clinical trial applications

Hogan Lovells on

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more

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