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GCP Renovation ICH Reflection on "GCP Renovation"

April 2017 Jones Day Publications
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") has released a reflection paper on Good Clinical Practice ("GCP") "Renovation," which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. Comments were solicited through March 11, 2017. ICH will review the comments received to determine whether to make revisions to the currently proposed approach. The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.
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