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Tuesday, June 16 • 2:00pm - 3:00pm
#233 L: Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-632-L04-P; CME 1.00; IACET 1.00; RN 1.00

Evaluation of risk evaluation and mitigation strategies programs in the US or additional risk minimization measures (aRMM) in the EU is required by regulatory bodies in their respective jurisdictions, though the approach, timing, requirements, and available guidance varies. Due to regulatory and cultural differences in global risk minimization practices, successful evaluation of risk minimization programs can be challenging. This forum will share views from varying stakeholder perspectives in the US and Europe for consideration in regulatory discussion, design, and implementation of these programs. Special consideration for practical implementation across different geographic regions in light of a pandemic to meet different regulatory requirements will be discussed. Practical challenges to evaluation implementation (e.g. identification of target population, controlling for selection bias, design options for process and outcome measures and cultural adaptation and consideration—will be discussed. Areas of benefit-risk management and communication will include: Rigorous approaches for evaluation, and practical considerations for planning for evaluation of risk minimization tools Presenters will share examples from their experiences for consideration in the planning, design, and implementation of evaluation of risk minimization programs, with focus on global implementation.

Learning Objectives

Identify at least three design considerations for evaluation of risk minimization programs that should not be compromised despite challenges to resource and logistics; Recognize at least two practical considerations in design of evaluation of a global risk minimization program in light of a pandemic.


Alicia Gilsenan, PhD, MS, RPh


Considerations for REMS Evaluation from US Regulatory Perspective
Cynthia LaCivita, PharmD

Special Considerations for Evaluation of Additional Risk Minimization Measures: European Perspective
Annalisa Rubino, DrSc, PhD, MSc

Practical Considerations for Global Evaluation of REMS and aRMM from Industry Perspective
Meredith Smith, DrPH, PhD, MPA

avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
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 →

Annalisa Rubino

Director of Epidemiology, AstraZeneca
Annalisa Rubino is a Director Epidemiology at AstraZeneca, with extensive experience in the strategic and scientific planning, conduct and critical appraisal of complex epidemiological studies to evaluate safety, effectiveness and value of medicines in various therapeutic areas. Her... Read More →
avatar for Cynthia LaCivita

Cynthia LaCivita

Director, Division of Risk Management, OMEPRM, OSE, CDER, FDA, United States
Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice... Read More →

Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum