Best Practices, LLC Study Examines How Pharmaceutical Industry is Successfully Executing Risk Evaluation and Mitigation Strategies Programs
CHAPEL HILL, N.C., Oct. 18, 2017 /PRNewswire/ -- Developing an effective, yet innovative, Risk Evaluation and Mitigation Strategy (REMS) plan is a delicate balancing act for pharmaceutical companies.
Given the complexity of balancing regulatory requirements and commercial objectives, Best Practices, LLC conducted a study to examine how leading life sciences and medical device companies develop and execute successful REMS plans for newly-approved drugs in the U.S. market. To inform these efforts, Best Practices, LLC published "REMS Excellence: Models & Trends in Supporting REMS Program Success."
Most companies start REMS planning for a new product during Phase III or earlier, and organizations use new technology, certification and similar tools to guarantee compliance by physicians and distributors, according to the study.
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 on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.
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.
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
Twenty leaders from 17 leading biopharmaceutical and medical device companies participated in this study.
To learn more about this report, download a complimentary report excerpt at http://www.best-in-class.com/rr1469.htm.
For related research, visit our Best Practices, LLC Web site at www.best-in-class.com/.
ABOUT BEST PRACTICES, LLC
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.