EMA plans to revise guidance on first-in-human clinical trials

Comments invited on a concept paper on changes intended to support best practices

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper, which has been released for public consultation. Comments on the proposals should be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. until 30 September 2016 using the form provided.

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