Module 1.5 REMS Components

Select a Module Module Details Review Materials Take Quiz Evaluate Module Print Certificate

This module provides an overview of the core components and structural models that define Risk Evaluation and Mitigation Strategies (REMS) programs. It explains the three primary REMS program models (Single Sponsor, Bifurcated, and Single Shared System) their operational structures and the regulatory circumstances under which the FDA requires each. The module also introduces additional program models, including Closed or Controlled Distribution and Hosted REMS, and clarifies their intended purpose and limitations. Finally, it outlines the key elements of REMS programs, with particular emphasis on Elements to Assure Safe Use (ETASU), describing when these elements are required and the types of controls they may involve to ensure safe medication use.