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Navigating the Gray Areas of Post-Marketing Surveillance

CHAPEL HILL, N.C., Jan. 28, 2011 /PRNewswire/ -- Drug safety remains front and center for the U.S. Food and Drug Administration as the agency strives to improve the public's perception of the organization. Likewise, the pharmaceutical industry is focused on improving its reputation among consumers and recognizes that its diligence in the reporting of adverse events plays an important role in that effort.

One issue that is impacting both these efforts is the approach to post-marketing surveillance for adverse events for gray areas like the Internet where reporting practices vary across the pharma industry. A Best Practices, LLC post-marketing surveillance study found that 50 percent of the participating companies don't collect AE reports from Internet sources such as blogs or interactive Web events.

Best Practices, LLC has published this report to help drug safety leaders navigate the gray areas of the regulations regarding the reporting of adverse events. Best Practices for Post-Marketing Surveillance of Adverse Events within the United States delivers not only metrics around drug safety reporting processes and sources, but also staffing, follow-up activities and compliance training. Drug safety leaders from 15 organizations shared their practices and insights into the evolving state of post-marketing surveillance of adverse events.

Key topics of this report include:

  • Staff Number (FTEs) and Makeup in Drug Safety Groups
  • Employee Groups Involved in AE Report Assessment
  • Process for Evaluating Adverse Event Reports
  • Most Common Reporting Sources of Adverse Event Reports
  • Main Methods for Follow-Up Activities
  • Adverse Event Report Training
  • Reporting Approach from Various Sources

Review a complimentary summary of the study at Executives, directors and managers at pharmaceutical and biotech organizations who work in drug safety or pharmacovigilance functions can use this research to compare their group's staffing, makeup, AE evaluation process, follow-up activities and training with those of leading organizations.


Best Practices, LLC, conducts work based on the simple yet 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. Best Practices, LLC has been a leader in pharmaceutical research and consulting for 17 years; our clients include 48 out of the top 50 pharmaceutical companies. For more information visit:

SOURCE Best Practices, LLC
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