Module 2.2 Framework and Structure of REMS

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REMS Industry Consortium – Module 2.2: Framework and Structure of REMS provides an overview of how to design, implement, and evaluate an effective Risk Evaluation and Mitigation Strategy (REMS) program. The module outlines the core REMS elements—such as Medication Guides, communication plans, Elements to Assure Safe Use (ETASU), and implementation systems—while emphasizing early risk identification, benefit–risk assessment, and proportionate mitigation strategies. It explores the roles and responsibilities of key stakeholders, including the FDA, cross-functional industry teams, healthcare providers, and patient advocacy groups, and highlights the importance of collaboration throughout the product lifecycle. Learners are introduced to FDA’s REMS Logic Model framework, best practices for defining goals and requirements, developing and validating REMS materials, and operationalizing and evaluating program effectiveness. The module concludes with practical guidance on stakeholder engagement, measurable compliance objectives, technology utilization, and continuous improvement to ensure REMS programs remain effective, compliant, and patient-centered.