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Pharma Firms Fear Diminished Role In Revised EU Signal Detection Guideline

Executive Summary

The European Medicines Agency recently revised its guideline on signal management to clarify the roles and responsibilities of concerned stakeholders and related terminology, among other things. However, the industry believes that these key aspects need to be further addressed to ensure that the role of marketing authorization holders is not diminished and that there is clarity on procedural aspects, such as calculating the Day 0.

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