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Pharma Industry Re-examining Strategies for Dealing with Gray Areas of Adverse Event Reporting

CHAPEL HILL, N.C., April 11, 2014 /PRNewswire/ -- The reporting of adverse events plays an important role in helping the pharmaceutical industry to improve its reputation among consumers. Likewise, drug safety remains at the forefront of the U.S. Food and Drug Administration's attention as they are also trying to improve the public's perception of the organization. As companies continue to grow, they are ever more expected to capture and react to their adverse events faster and more efficiently. Even one small slip in this area can have disastrous consequences, both to public safety and the bottom line.

While organizations report adverse events from a variety of sources, there are still some areas that organizations are ignoring. According to research by benchmarking firm, Best Practices, LLC, more than 50% of participating companies do not report adverse events from Internet sources such as blogs and chat rooms. The research found that post-marketing surveillance for gray areas like the Internet greatly vary across the pharma industry as a whole.

The report, "Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S.," contains metrics and insights that will help drug safety leaders to successfully navigate the gray areas of the regulations regarding the reporting of adverse events. The research also identifies the processes for assessing reports of adverse events, follow-up activities and compliance training.

Key topics of this report include:

  • Staffing and Workflow
  • Drug Safety Processes and Reporting Sources
  • Approach to AE Reports From Non-Traditional Sources
  • Approach to AE Reports on Another Manufacturer's Product
  • Drug Safety Compliance Training
  • Marketing Program Involvement
  • Drug Safety Challenges

This benchmarking research drew participation from 15 bio-pharmaceutical companies. Executives shared their strategies, lessons learned, and best practices on Post-Marketing Surveillance. Job titles of participants include senior vice president, vice president, senior director, director, and medical director.

To access the full report, or to download a complimentary summary containing insights found in this report, click on the following link:

For more information on other recent primary research studies, contact us at 919.403.0251. For related research, visit our Best Practices, LLC website 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. 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. Best Practices, LLC believes in the profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.

SOURCE Best Practices, LLC

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