Medical and scientific progress has been enormous in the past decades. However, this has also raised several safety issues leading to increased vigilance on bio-pharma companies by the U.S. Food and Drug Administration Authority. Under such circumstances, it is imperative for the bio-pharmaceutical industry to maintain a dynamic post-marketing surveillance system to ensure regulatory compliance.
This benchmarking study examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.
Executives and managers in Drug Safety can use this research to compare their group's staffing, makeup, AE evaluation process, reporting sources, follow-up activities and training with those of leading organizations.