FDA’s Risk Evaluation and Mitigation Strategy (REMS)

  • Product Id : FDB2807
  • Category : , ,
  • Presenter :
  • Scheduled On : December 14 2020 1:00 pm
  • Duration : 90 Minutes

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

FDB2807

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.

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  • Presentation Handout in .pdf format
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