Module 2.3: Development of an Implementation System

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

Module 2.3: Development of an Implementation System, provides a comprehensive overview of how drug manufacturers design, operate, and maintain a formal framework to monitor and improve Risk Evaluation and Mitigation Strategies (REMS), specifically regarding Elements to Assure Safe Use (ETASU). It outlines the regulatory mandates under Section 505-1 of the FD&C Act, details the critical phases of system development—such as identifying requirements, stakeholder collaboration, and documentation—and explains daily operational infrastructure, including compliance monitoring, continuous improvement workflows, and validated database management.