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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. As the agency puts more resources into post-marketing surveillance, the industry is responding by re-examining its reporting protocols and how it deals with the gray areas of the regulations regarding the reporting of adverse events.
With this in mind, Best Practices, LLC has created an important new benchmarking study that examines best practices for post-marketing reporting of adverse events.
This pharmaceutical and biotechnology-focused study is designed to explore where companies receive adverse event reports from and whether they report events from non-traditional sources. The study also examines the effectiveness of different methods for collecting follow-up data.