FDA’s Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.

REMS are not designed to mitigate all the adverse events of a medication, these are communicated to health care providers in the medication’s prescribing information. Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.

Areas Covered in the Session :

• Overview of REMS Elements
• 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
• Validation Departments
• Quality Engineers