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#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25

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 Objectives

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.

Chair

Daniele Sartori, MSC

Speaker

Panelist
Gita Toyserkani, PHARMD, MBA

Panelist
Elaine Lippmann, JD

Panelist
Helga Gardarsdottir, FISPE

Panelist
Priya Bahri, PHD


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Helga Gardarsdottir

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands
Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →
avatar for Elaine Lippmann

Elaine Lippmann

Principal, Leavitt Partners, United States
Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
avatar for Gita Toyserkani

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States
Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
  • Tags Session

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