REMS: The New Secret to Product Success?

REMS: The New Secret to Product Success?

FDA mandated Risk Evaluation and Mitigation Strategies (REMS) are often viewed as obstacles to product access.  Having supported more than 100 REMS programs, UBC has a different perspective.  We view REMS programs as paths to prescriber loyalty and commercial success.

Every REMS program has distinctions that require careful thought to address.  As an industry leader in the design and implementation of REMS, UBC experts can help:

  • Identify products that require risk assessment or risk mitigation
  • Design, implement, and evaluate risk assessment and risk minimization programs to meet regulatory requirements
  • Design and implement disease and product registries to meet regulatory requirements and address commercial objectives
  • Examine real-world use of drugs and associated outcomes
  • Understand product safety issues and risk factors at the patient level
  • Prepare safety reports and manuscripts for regulatory, product marketing, and medical communications

And, whether or not your product will require a REMS, proactive planning can help you prepare for post-marketing safety requirements.

Click here to access our free whitepaper “100 REMS Programs and Counting – Top Lessons Learned,” by leading industry expert, Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries, and Risk Management.