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

During this course, the important interfaces between GMP and GCP will be elaborated.

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

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