Best Practices, LLC Report on Post-Marketing Surveillance Programs Sheds Light on Gray Areas of Adverse Event Reporting

Friday, April 23, 2010 Medico Legal News
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CHAPEL HILL, N.C., April 22 The reporting of adverse events continues to be a critical activity for the pharmaceutical industry and its importance is clear as the U.S. Food and Drug Administration increases its focus on post-marketing surveillance for adverse events. Yet when it comes to gray areas like the Internet, 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 adverse events reports from Internet sources such as blogs or interactive Web events.

This 37-page report will 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 such as Novartis, Novo Nordisk, Takeda, Boehringer Ingelheim, Wyeth and Amgen shared their practices and insights into the evolving state of post-marketing surveillance of adverse events.

Download a complimentary report summary at: http://www3.best-in-class.com/rr995.htm.

Key topics of this report include:

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.

To learn more about Best Practices' other timely research visit: http://www3.best-in-class.com or contact Jeff Zimmer at 919-767-9180 or jzimmer@best-in-class.com.

ABOUT BEST PRACTICES, LLC

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 46 out of the top 50 pharmaceutical companies. For more information visit: http://www3.best-in-class.com.

-- 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

SOURCE Best Practices, LLC


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