Module 2.6 REMS Contingency Planning

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Module 2.6 on REMS Contingency Planning focuses on the critical role of proactive contingency planning in ensuring the continuous execution of Risk Evaluation and Mitigation Strategies (REMS) during unexpected operational, technical, or regulatory disruptions. It defines contingency plans as pre-approved, documented strategies designed to preserve Elements to Assure Safe Use (ETASU) and maintain patient safety protections when standard operational channels fail. The module guides REMS professionals through the complete lifecycle of contingency planning—from risk prioritization using structured methodologies like FMEA to plan execution, vendor oversight, and regulatory communication. Ultimately, the training emphasizes creating actionable, testable, and compliant fallback controls—such as paper-based workflows or temporary verification channels—to mitigate disruptions and ensure uninterrupted compliance and safety.