REMS Training Courses (LMS)

RIC’s Learning Management System is designed to offer a training resource to those new to the Risk Evaluation and Mitigation Strategy (REMS) community.  This course was developed by REMS Professionals with an eye on expanding the expertise of the REMS community and sharing best practices.  Below is an outline for the entire program as it is currently envisioned.  Each module will be published upon completion.

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Envisioned Course Outline:

Module 1: REMS Design and Planning

  • Initial Assessment: What is a REMS? / Environmental Scan (Published)
  • Internal Collaboration (Published)
  • FDA Negotiations (Published)
  • Stakeholder Perspectives
  • REMS Components
  • REMS Submissions
  • Noncompliance Plan
  • Planning for Assessment Reports
  • Audit Plan
  • Vendor Selection
  • Overview of Design & Planning

Module 2: Development

  • Vendor Selection
  • Framework/Structure of the REMS 
  • Development: REMS Coordinating Center/Database/Website 
  • Planning for Assessment Report 
  • Internal Collaborations (Internal Governance/SOP/Budget)  
  • Contingency Planning 
  • Overview of Build & Implementation (Individual REMS v. Shared REMS)

Module 3: General Operations

  • Program Management / Inspection Readiness 
  • Vendor Management / Overview / Vendor Audits 
  • REMS Coordinating Center/Database/Website 
  • Noncompliance Management 
  • Modifications 
  • Assessment Reports 
  • Release of Commitment  
  • Overview of General Operations (Individual REMS v. Shared REMS)

Module 4: Regulatory (FDA) Interactions

  • Understanding Existing Guidances 
  • Engagement/Expectations 
  • FDA Information Requests 
  • Inspection Readiness  
  • Overview of Regulatory (FDA) Interactions (Individual REMS v. Shared REMS) 

Module 5: Shared REMS

  • Formation (Governance / Vendor)
  • Reference Technical Conformance Guidance for Shared REMS 
  • Design and Development 
  • Sponsor Engagement
  • Transition 
  • General Operations
  • Assessment Reports 

If you are a RIC Member and you would like to contribute to the development of this traiing program, please be sure to Join the Education & Certification Working Group!