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