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EFPIA Picks Holes With EMA's Revised Guidance On Risk Management Plans

This article was originally published in SRA

Executive Summary

The European Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help remove "several redundancies present in the current version" of the guidance. However, EFPIA has significant concerns over certain other parts of the revised guideline, such as the rewording of certain sections that it believes could be misinterpreted by those enforcing the guideline and create confusion.


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