The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), has recently consulted on a concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’.
The concept paper sets out proposed changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. Our response to this consultation can be found here.