Navigating REMS: Article Series

Risk Evaluation and Mitigation Strategies (REMS) play a critical role in protecting patient safety, by requiring sponsors to take specific steps to ensure the benefits of a product outweigh its potential risks. However, when facing a complex web of regulatory requirements, coordination among various stakeholders, and integration with broader market strategies, sponsors may become overwhelmed by the variables and complexities that arise. Finding the right REMS solutions for a product’s specific needs can become an impenetrable challenge.

Navigating REMS is a four-part insight series to guide sponsors through the pain points often encountered throughout the lifecycle of a REMS. Drawing on decades of REMS support and expertise, including launching the first-ever REMS, UBC shares proven strategies that enable sponsors to prepare for and navigate the processes, milestones, and challenges involved in patient safety programs and REMS compliance, development, implementation, and assessment.

What you’ll get

The second article in the series, Synergizing Safety: Improving Efficiencies with Shared System REMS, explores the practicalities of building a coordinated REMS program. Through a shared system REMS, multiple drug applicants work together to manage shared safety risks under a unified strategy — helping to overcome the REMS complexities that arise when a drug’s patent expires and generic versions begin to enter the market. Read the article to learn:

• When and how a shared REMS system should be established
• Approaches to facilitate cooperation among various stakeholders
• Strategies for optimizing efficiency in a shared REMS system
• Practical considerations for operational and structural challenges
• Additional insights and REMS strategies

If you missed the first article, Inside REMS FDA Inspections, which includes a REMS compliance checklist for sponsors, click below to download.