Module 1.7 Noncompliance Plan

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This module provides an overview of developing and implementing a REMS noncompliance plan, which defines how stakeholder noncompliance with legally required REMS elements is identified, evaluated, escalated, and resolved. Participants learn the purpose and scope of a noncompliance plan, including the roles and responsibilities of all parties involved, classification of noncompliance events, and appropriate corrective actions. The module covers best practices for documenting and tracking compliance through audit plans and quality management systems, outlines the function of the Compliance Assessment Committee, and discusses considerations for shared REMS programs. Guidance is provided on integrating the noncompliance plan into REMS documents, supporting documentation, or assessment reports, as well as requirements for initial approval, post-launch updates, and ongoing training to ensure program adherence.