The European Medicines Agency’s updated guideline on risk minimization and the measures drug sponsors should take to ensure their products are used safely places greater emphasis throughout on the need to involve health care professionals and patient representatives in designing, testing, disseminating and evaluating the effectiveness of such measures.
Key Takeaways
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The European Medicines Agency held a webinar to discuss its revised guideline on risk minimization measures (RMMs) and the related addendum on evaluating RMMs.
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At the event, the EMA clarified the revised structure of the RMM guide, explained new terminologies and explained the reason for some of the changes.
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The agency explained why there is greater emphasis throughout on involving health care professionals (HCPs) and patient representatives in designing, testing, disseminating and evaluating RMMs
While most risks for drug products can be sufficiently managed by routine risk minimization measures (eg, summary of product characteristics, package leaflet), others may require the use of additional RMM tools (eg,