Gilsenan A, LaCivita C. Practical considerations for robust evaluation of risk minimization programs: regulatory, industry, service provider insights. Presented at the 2020 DIA Virtual Conference; June 14, 2020. Washington, DC.

Evaluation of risk evaluation and mitigation strategies (REMS) programs in the United States or additional risk minimization measures (aRMM) in the European Union is required by regulatory bodies in their respective jurisdictions, although the approach, timing, specific requirements, and available guidance for best practice varies. Due to the regulatory, country-specific, and cultural differences in global risk minimization practices, successful evaluation of risk minimization programs can be challenging. This forum will provide participants with views from varying stakeholder perspectives in the United States and Europe from regulatory, industry, and researchers for consideration in the regulatory discussion, design, and implementation phase of these programs. Special consideration for practical implementation across different geographic regions to meet different regulatory requirements will be discussed. Practical challenges to rigorous evaluation implementation— including 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 of risk minimization tools 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.

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