Menu Back toRisk Minimization Program Evaluation: How Can we Advance the Science?

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

  • 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.

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