FDA's Latest Guidance on Risk Evaluation and Mitigation Strategy (REMS)

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

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.