Risk Management, RMPs, and REMS

Risk Evaluation and Mitigation Strategy Design

What is a Risk Evaluation and Mitigation Strategy?

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy beyond product labeling to manage known or potential risks associated with a drug or biological product. The FDA may require manufacturers to develop, implement, and evaluate the effectiveness of such a strategy to ensure that the benefits of a product outweigh its risks.

After it is decided that a product may require a REMS, careful analysis, planning, and strategic approach to program design are critical to determining which elements may be most appropriate to mitigate the risks without creating undue burden on internal and external stakeholders. Purposefully selecting elements in a hierarchy from least to most restrictive is central to REMS design, effective contingency planning, and an increasing the likelihood of acceptance by the FDA.

What makes the ParagonRx approach to REMS unique?

ParagonRx offers uniquely customized support:

  • Evidence-based methods that align with FDA’s current thinking (e.g., ethnographic research, care process mapping, failure mode and effects analysis [RxFMEA®])
  • ParagonRx has been shaping the risk management discipline while working with and advising clients since 2001.
  • Our services are customized to meet the needs of our clients and regulatory expectations.
  • We are highly experienced in creating REMS documents of varying levels of complexity.
  • Our track record is unsurpassed: all REMS documents have been submitted to FDA within client timelines and/or regulatory commitment dates, and none were rejected or required rewrites.