EMEA Holds Workshop on First-in-Man Clinical Trials Draft Guideline

GMP News
11 July 2007

EMEA Holds Workshop on First-in-Man Clinical Trials Draft Guideline

As the European Medicines Agency (EMEA) issued in a recent press release, it held a workshop on 12 June 2007 "as part of the public consultation on the draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products."

With the draft guideline the authority wants to provide support for transitioning "from non-clinical studies, e.g. studies in animals or in vitro studies, to first tests in humans. It describes the principles of a science-based approach ensuring the safety of subjects and respecting ethical principles while allowing for flexibility."

For identifying potential risks and for implementing risk management strategies for the phase I clinical trials some criteria have to be considered. These criteria are also covered in the draft guideline. During the public consultation phase these were generally supported. However, it also generated a major debate on the concept of classification of high-risk versus non-high-risk medicinal products. As noted in the release, the EMEA will consider the proposals "to replace it with a risk management and risk mitigation approach based on the concept of risk as a continuum for all medicinal products".

The Agenda of the workshop and presentations given can be found here: http://www.emea.europa.eu/postconference.htm

The draft guideline can be found here: http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf

Source: EMEA press release

Hear essential aspects about the organisation and management of clinical trials, IMP distribution and things to consider during the study at the ECA Education Course

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Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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