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Wednesday, June 30 • 2:00pm - 3:00pm
#334 SL: Risk Minimization Program Evaluation: How Can we Advance the Science?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-614-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Meredith Smith, PhD, MPA, FISPE


Almut G Winterstein, PhD, RPh, FISPE

Giampiero Mazzaglia, MD, PhD, MSc

Rachael L. DiSantostefano, PhD, MS

Vincent Lo Re, MD, MS, FISPE

Gianluca Trifiro, MD, PhD

avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Rachael DiSantostefano

Rachael DiSantostefano

Senior Director, Epidemiology, Janssen Research & Development, LLC, United States
Rachael L. DiSantostefano, MS PhD, is a Senior Director in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has more than 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes... Read More →
avatar for Giampiero Mazzaglia

Giampiero Mazzaglia

Associate Professor of Hygiene and Public Health, University of Milan, Italy
Prof. Mazzaglia is graduated in medicine with post-graduate degrees in pharmacology, microbiology, and epidemiology and particular interest in the field of pharmacovigilance, pharmacoepidemiology and risk management. In 2010 he was appointed by the European Medicine Agency as “co-opted... Read More →

Vincent Lo Re

Associate Professor, U of Penn; Regional Editor of Americas, PDS, Pharmacoepidemiology and Drug Safety, United States
Vincent Lo Re, M.D., M.S.C.E. is Associate Professor of Medicine (Infectious Diseases) and Epidemiology at the University of Pennsylvania, Senior Scholar in the Penn Center for Clinical Epidemiology and Biostatistics, and Senior Investigator in the Penn Center for Pharmacoepidemiology... Read More →
avatar for Gianluca Trifiro

Gianluca Trifiro

Scientific Lead, INSPIRE; Professor, Pharmacology, Diagnostics and Public Health, University of Verona, Italy
Gianluca Trifirò is MD, clinical pharmacologist and pharmacoepidemiologits working as Associate Professor of Pharmacology at the Academic Hospital of Messina with honorary position at Department of Medical informatics of Erasmus Medical Center of Rotterdam (NL). Scientific coordinator... Read More →
avatar for Almut Winterstein

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 →

Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum