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DIA 2021 Global Annual Meeting
Risk Minimization Program Evaluation: How Can we Advance the Science?
Meredith Smith, PhD, MPA, FISPE
- Director, Risk Management, Global Drug Safety, Research and Development
- Alexion Pharmaceuticals, United States
This forum will explore the use of different evaluation designs and measurement approaches to advance the science of risk minimization program evaluation and include a recent case study to illustrate points.
Learning Objective : Define methodologic features of high-impact risk minimization program evaluation designs; Review existing risk evaluation and mitigation strategies (REMS) case studies and opportunities to improve their evaluation, including consideration of contextual factors and assessment of potential burden on the healthcare system; Describe how to improve the likelihood of publication of evaluation studies.
Almut G Winterstein, PhD, RPh, FISPE
- University of Florida, United States
Giampiero Mazzaglia, MD, PhD, MSc
- Associate Professor of Hygiene and Public Health
- University of Milan, Italy
Rachael L. DiSantostefano, PhD, MS
- Senior Director, Epidemiology
- Janssen Research & Development, LLC, United States
Vincent Lo Re, MD, MS, FISPE
- Associate Professor, U of Penn; Regional Editor of Americas, PDS
- Pharmacoepidemiology and Drug Safety, United States
Gianluca Trifiro, MD, PhD
- Scientific Lead, INSPIRE; Professor, Pharmacology, Diagnostics and Public Health
- University of Verona, Italy