Understanding REMS

As regulations around patient safety continue to evolve in the life science industry, most likely your organization has already considered or moved forward with a plan to establish a Risk Evaluation and Mitigation Strategy (REMS). For many organizations, REMS is a critical requirement that can directly impact the success of their product approval and positioning.

On-Label Regulations Through its alliance with Axiom, a Huntsworth Health Company, PharmaCertify is now offering Understanding REMS, an off-the-shelf eLearning module that will help your organization jumpstart the process of understanding the impact of REMS. Educating various departments within your organization on risk management, and specifically on REMS, is essential for achieving success in today’s highly regulated marketplace.

After completing the Understanding REMS module, learners will be able to:

Define risk management
Recognize the evolution of risk management plans leading up to the current requirement of REMS for certain products
Describe the key differences between REMS and risk minimization action plans (RiskMAPs)
Describe REMS and its goal
Identify possible REMS elements
Recognize possible penalties for violating a REMS

To learn more about each course in our compliance curriculum, click one of the titles listed on the right.

Available Modules