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Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights
Session Chair(s)
Alicia Gilsenan, PhD, MS, RPh, FISPE
Vice President, Epidemiology
RTI Health Solutions, United States
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 Objective : 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.
Speaker(s)
Considerations for REMS Evaluation from US Regulatory Perspective
Cynthia LaCivita, PharmD
FDA, United States
Director, Division of Risk Management, OMEPRM, OSE, CDER
Special Considerations for Evaluation of Additional Risk Minimization Measures: European Perspective
Annalisa Rubino, DrSc, PhD, MSc
AstraZeneca, United Kingdom
Director of Epidemiology
Practical Considerations for Global Evaluation of REMS and aRMM from Industry Perspective
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
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