EFGCPEuropean Forum for Good Clinical Practice
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the EFGCP workshop on risk-based monitoring and a number of regional pharmaceutical and biotechnology events.
According to EFGCP, the problem arises because the requirements are an accumulation of all the existing national requirements in the EU, instead of a simplification: "The past 12 years of debate on European good clinical practice and the need for a general European clinical trials framework is very much at stake in the specifics of what this set of guidance proposes".
At the same time, EFGCP has been pursuing some detailed examination of other areas of European clinical trials regulation.