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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 (UMC), 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 : Discuss 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.
Speaker(s)
Panelist
Gita Toyserkani, MBA
Perspective Pharmacovigilance, United States
Regulatory Strategy Lead
Panelist
Elaine Lippmann, JD
Leavitt Partners, United States
Principal
Panelist
Helga Gardarsdottir, PHARMD, PHD, FISPE
Utrecht University, Netherlands
Professor RWD for decision making on medicines
Panelist
Representative Invited
European Medicines Agency, Netherlands
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