Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines

• Date:
  Tuesday, 28 March 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) held a public consultation a concept paper which outlined the major areas for revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products', from July to September 2016. Subsequently, EMA published a draft revised guideline for public consultation, from November 2016 to February 2017. This technical workshop aims to finalise the guidance with further involvement of stakeholders including from other regulatory agencies, pharmaceutical industry, contract research organisations and academia. The focus of the workshop will be on discussing comments received during the public consultations, therefore participation of external stakeholders is limited to those individuals and organisations who submitted comments. The output of the workshop will be reflected in the final revised guideline and the published overview of comments.