🎤  Kelly Thomas    |  📅 February 29, 2024   |  🕒  11 AM Eastern Time US


A Risk Evaluation and Mitigation Strategy (REMS) is a vital drug safety initiative that the U.S. Food and Drug Administration (FDA) can mandate for specific medications with serious safety concerns, ensuring a careful balance between the benefits and risks of the medication. Unlike the standard medication labeling that informs healthcare stakeholders about potential risks, only a select few medications necessitate a REMS.

Importantly, REMS doesn't aim to mitigate all possible adverse events, which are communicated separately in the medication’s prescribing information to healthcare providers. Instead, REMS is laser-focused on preventing, monitoring, and managing specific serious risks. Through informed education and reinforcement, it strives to reduce the frequency and severity of these events, providing a targeted approach to enhancing medication safety. This webinar is your passport to understanding how REMS goes beyond mere risk mitigation. 

Areas Covered in the Session : 

  • Overview of REMS Elements
  • Latest FDA Guidance
  • Shared Systems REMS
  • The REMS Inspection Process
  • Best Practices to Address Inspection Findings
  • REMS Specific Issues
  • Preparing for REMS Inspections

Who Should Attend:

  • Quality Assurance Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Risk Management Professionals
  • Validation Departments
  • Quality Engineers

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