REMS

Risk Evaluation and Mitigation Strategies or REMS, are a set of requirements put in place by the FDA to help ensure the safe use of medications with serious risks. These requirements can include things like patient registries, counseling, and special training for healthcare providers. These patient safety programs help mitigate risk associated with drug product that are marketed. Successful implementation of risk management activities require a plethora of moving parts to ensure compliance with regulatory requirements. The FDA can require a range of components based on the risk that are identified. Ensuring a loftier benefit of a drug than its associated risk is the intended goal of these important programs. Enhancing patient safety is the key benefit of any REMS!

While patient safety is critical to the profile of any drug with risk, the development and management of a REMS requires resources, experience and some specific planning for successful implementation. Niche areas like REMS often use a lot of company time and resources. Hiring an experienced consultant is the optimal approach to saving in these crucial areas for an organization. The savings and sleep for having experienced subject matter experts is priceless!!