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From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures
Session Chair(s)
Daniele Sartori, MSC
Senior Pharmacovigilance Scientist
Uppsala Monitoring Centre, Sweden
Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.
Learning Objective : Review the US and EU regulatory rationale and expectations for RMM evaluations; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.
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