Module 2.1 Service Provider Oversight

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Service Provider Oversight provides an overview of the sponsor’s responsibilities for overseeing service providers within REMS programs. The module explains why robust oversight is critical to patient safety and regulatory compliance, emphasizing that sponsors remain fully accountable for REMS requirements even when operational activities are delegated. Learners are introduced to key regulatory expectations, effective governance and oversight frameworks, and best practices for managing service providers through clear contracts, training, performance monitoring, audits, and data integrity controls. The module also addresses issue management, including deviation investigations, root cause analysis, and corrective and preventive actions (CAPAs), as well as the risks associated with insufficient oversight. Finally, it highlights the importance of continuous improvement, requalification, and documentation to maintain inspection readiness and ensure REMS programs remain compliant, effective, and aligned with evolving regulatory expectations.