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DIA 2021 Global Annual Meeting

Risk Minimization Program Evaluation: How Can we Advance the Science?

Session Chair(s)

Meredith Smith, PhD, MPA, FISPE

Meredith Smith, PhD, MPA, FISPE

  • Sr Director, Risk Management, Global Patient Safety
  • Alexion Astra Zeneca Rare Disease, 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.

Speaker(s)

Almut G Winterstein, PhD, RPh, FISPE

Panelist

Almut G Winterstein, PhD, RPh, FISPE

  • Professor
  • University of Florida, United States
Giampiero Mazzaglia, MD, PhD, MSc

Panelist

Giampiero Mazzaglia, MD, PhD, MSc

  • Associate Professor of Hygiene and Public Health
  • University of Milan, Italy
Rachael L. DiSantostefano, PhD, MS

Panelist

Rachael L. DiSantostefano, PhD, MS

  • Senior Director, Epidemiology
  • Janssen Research & Development, LLC, United States
Vincent Lo Re, MD, MS, FISPE

Panelist

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

Panelist

Gianluca Trifiro, MD, PhD

  • Scientific Lead, INSPIRE; Professor, Pharmacology, Diagnostics and Public Health
  • University of Verona, Italy