Name: Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science
Start: 2025-06-17T13:45:00-0400
End: 2025-06-17T14:45:00-0400

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

Risk mitigation (RM) decisions commonly lack conclusive data and reproducibility. This session presents regulatory initiatives, TRIM, the first tool to support RM decision-making, and case studies of evidence-guided RM implementation and evaluation.

Learning Objectives

Summarize new initiatives that support regulatory decision-making on risk mitigation; Explain the use of pharmacoepidemiologic and decision-science approaches in developing an explicit risk mitigation decision tool; Discuss how qualitative and quantitative evidence can support REMS implementation; Compare study design options for formal REMS evaluation.

Chair

Almut G Winterstein, PhD, RPh, FISPE

Speakers

Almut Winterstein

Professor, University of Florida, United States

Almut Winterstein is Professor and Chair in Pharmaceutical Outcomes & Policy and the founding Director of the Center for Drug Evaluation & Safety at the University of Florida. She was named the Dr. Robert and Barbara Crisafi Chair for Medication Safety in recognition of her research... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
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Tags Session

DIA 2025 Global Annual Meeting

Almut Winterstein

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