Metis Consulting Services
Pharmacovigilance Services, QA, Anaylsis, Process Development, Pre-Inspection Audit Readiness.

REMS

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Risk Evaluation & Mitigation Strategies ~ REMS

“A 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.” -Food & Drug Administration

The REMS program was introduced with the Food and Drug Administration Amendments Act of 2007 and requires post-marketing studies or clinical trials of human drugs as well as REM Strategy. This program utilizes a standardization of elements to endure the safe use of drugs with known serious risks so that REMS are not unduly burdensome for the health care delivery system, and do not needlessly limit patient access to drugs.

  • How are you managing your REMS evaluation and products?

  • What is your vendor oversight processes and procedures?

  • Where are the potential gaps in your system?

  • Where are the interdepartmental interactions to ensure compliance with REMS reporting?

Call us at (760) 443-2659 to learn more, or send us an email at info@ metisconsultingservices.com

Last updated: 9 October 2019