DIA 2020 Global Annual Meeting

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.