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Last updated on April 19, 2014 at 9:20 EDT

REMS Research Highlights Pharmaceutical Industry Trends in Supporting Risk Mitigation Programs

May 24, 2012

CHAPEL HILL, N.C., May 24, 2012 /PRNewswire/ — With regulators focused on the safety of new products, pharmaceutical organizations face increasing regulatory requirements for their new products. One of the outgrowths of these new regulations is that pharmaceutical companies must have the capability to develop effective Risk Evaluation & Mitigation Strategy (REMS) plans that will both protect the public and ensure access to their products.

Many companies have relatively limited experience in implementing a REMS plan or executing a REMS plan throughout the entire product lifecycle. A new Best Practices, LLC study found companies that participated in the study have only deployed, on average, REMS plans for 3.33 products since the advent of REMS through federal legislation in 2007. The most total REMS products managed by one company was nine, according to the study.

The study, “Risk Mitigation Plan Excellence: Innovative Models and Trends in Supporting REMS & RMP Programs,” provides critical insights into the quickly evolving REMS landscape and highlights opportunities for key support functions that deliver REMS support.

This research project examines how leading biopharma organizations:

  • Structure their REMS teams
  • Delegate key activities across functions
  • Balance regulatory imperatives and commercial objectives associated with REMS products
  • Use Market Research teams for maximum support and benefit
  • Analyze Risk Management Plan (RMP) lessons from the European market to find collaborative opportunities and efficiencies between RMP and REMS operations

Research and consulting firm Best Practices, LLC conducted the study to identify the most suitable structure and roles to support REMS programs as well as the role of market research in supporting REMs programs. In addition, the 64-page study examines the internal and external resources that leading organizations use to support REMS programs. The study also reviews the challenges of implementing communication plans and trends in the European market for implementing Risk Management Plans.

Research participants included 22 executives and managers from 19 leading pharmaceutical, biotech, and medical device companies. All study participants contributed data through a field survey and representatives from several leading benchmark organizations also provided additional insights through deep-dive interviews.

Biopharmaceutical leaders who are involved with REMS programs can use this study to compare their structure and roles for supporting REMS programs with the approach used by other leading organizations.

To access the full report or to download a complimentary summary, click on the following link: http://www3.best-in-class.com/rr1157.htm.

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. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations.

SOURCE Best Practices, LLC


Source: PR Newswire