As the pharmacovigilance landscape continues to evolve, the European Medicines Agency’s (EMA’s) revision of Module XVI of the Good Pharmacovigilance Practices (GVP) guideline is an important milestone.
The update, which was published at the beginning of August 2024, revises the framework for additional risk minimisation measures (RMMs), aligning them with emerging best practices in implementing, monitoring and evaluating drug safety measures, and provides updated definitions.
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