Module 2.4: Development of an Assessment Report

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Module 2.4 on developing an assessment report outlines the development of a Risk Evaluation and Mitigation Strategies (REMS) Assessment Report to ensure regulatory compliance and inspection readiness. Grounded in FDA authorities and guidance documents, the module introduces a shared, cross-functional framework for planning, executing, and reporting REMS assessments. Participants will learn how to apply the FDA's REMS logic model, build structured assessment plans using diverse data sources, and properly format reports according to FDA specifications—ranging from executive summaries to proposed program modifications. Ultimately, the course emphasizes that accurate, cross-functional REMS assessments are a critical compliance obligation necessary to determine if specific serious drug risks are being effectively mitigated in the real world.