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"The Role of Market Research in the Reporting of Adverse Events by Third-Party Vendors"
As the U.S. Food and Drug Administration sharpens its focus on safety, there is more attention on post-market surveillance of products through adverse event (AE) reporting. This benchmarking study examines market research’s role in reporting adverse events uncovered by third-party vendors, in particular those in market research and analytics roles.
The study data and findings provide insight to market research and business intelligence executives and managers about how the pharmaceutical industry applies FDA regulations that require pharmaceutical manufacturers to be responsible for reporting adverse events relating to their drugs on market. The study includes FDA regulations surrouding AE reporting and information from a Best Practices, LLC interview with an FDA compliance officer.