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EMA Proposes Significant Changes To Guidance On Risk Management Plans And Template

This article was originally published in SRA

Executive Summary

The European Medicines Agency has proposed significant changes to its pharmacovigilance guideline on risk management plans to further clarify how drug companies should address identified or potential risks of a drug and tackle "missing information" about a product in an RMP. Also, major changes have been proposed to the integrated RMP template1,2.


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Companies Use Revised EU Risk Management Plan Template Ahead Of Mandatory Deadline
EU Generic Industry Group Looks At Radical Options To Simplify Pharmacovigilance Tasks
EMA Revises Guidance On Risk Management Plans To Address Industry ‘Misunderstandings’



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