Navigating the Gray Areas of Post-Marketing Surveillance
CHAPEL HILL, N.C. – January 28, 2011. 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 http://www.best-in-class.com/rr1040.htm. 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.
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. 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.