RIC Learning Management System

This course is aimed at providing the participant with an understanding of the factors in FDA Decision Making when requiring a REMS; the elements of a REMS Program, and the Elements to Assure Safe Use (ETASU) in designing a REMS Program.

This course is aimed at providing the participant with an understanding of the internal collaborators needed to design and plan a REMS Program, including the role of the Point of Contact and the REMS Oversight Committee.

FDA Negotiations: providing the participant with an understanding of the process by which a REMS Program comes into being, and what to expect from the FDA, and when, in designing a REMS Program for New Drug Applications, Biologic License Applications,

This module provides an overview of the key external stakeholders involved in REMS (Risk Evaluation and Mitigation Strategy) programs and examines how each group interacts with and is impacted by REMS requirements.

This module provides an overview of the core components and structural models that define Risk Evaluation and Mitigation Strategies (REMS) programs.

This module provides a more in-depth overview of the end-to-end process for developing, preparing, and submitting Risk Evaluation and Mitigation Strategy (REMS) submissions to the FDA.

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.

Module 1.8 provides a comprehensive overview of developing a REMS Assessment Plan and the role it plays in evaluating the effectiveness of a REMS program over time.

This module provides an overview of developing and finalizing an audit plan for REMS stakeholders, which ensures compliance with REMS requirements and supports the noncompliance plan submitted to the FDA.

Module 1.10: Service Provider Selection provides an overview of the structured, risk-based approach required to identify, evaluate, and manage service providers that support REMS programs.

Module 1.11: Single REMS vs. Shared REMS Design and Planning provides an overview of the regulatory and operational considerations involved in designing and managing single-system versus shared-system REMS programs.