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At Decade Mark, how are Pharmaceutical Companies Successfully Executing Risk Evaluation and Mitigation Strategies Programs?

CHAPEL HILL, N.C., July 17, 2017 /PRNewswire/ -- It has been 10 years since the U.S. Food and Drug Administration gained the authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) for products that may have safety issues.

Given the complexity of balancing regulatory requirements and commercial objectives, research and consulting leader Best Practices, LLC conducted a research project to examine how leading life sciences companies develop and execute successful REMS plans for newly-approved drugs in the U.S. market. The study, "
REMS Excellence: Models & Trends in Supporting REMS Program Success," provides current trends and best practices for creating REMS plans.

The study found that most companies have relatively limited experience in implementing a REMS plan. On average, benchmark companies have only deployed REMS plans for 4.7 products since the Food and Drug Administration's Amendments Act of 2007 was issued. With REMS requirements so infrequent for most drug manufacturers, it is critical to leverage as much internal experience as possible.

In particular, the study provides insights around the structure and responsibilities of REMS teams, use of internal and external resources to support REMS programs, physician/ distributor compliance, current challenges in REMS communication plans and innovative REMS approaches for new products.

Key topics covered in this new report include:
  • REMS Program: Structure & Responsibilities
  • Industry Experience In Developing & Deploying Successful REMS Plans
  • REMS Approaches For New Products
  • Leveraging Resources For REMS Efficiency & Excellence
  • REMS Communication Plans: Current Challenges

The study is based on insights from 20 leaders from 17 leading biopharmaceutical and medical device companies.

To learn more about this report, download a complimentary report excerpt at

For related research, visit our Best Practices, LLC Web site at


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

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