Pharma R&D Today
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Pharmacovigilance: Rethinking Literature Monitoring and Review
Posted on October 27th, 2015 by Neal Katz in Pharmacovigilance
Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.” Under that umbrella, government agencies in the United States, the European Union and other parts of the world have developed diverse and increasingly complex regulatory requirements. A key component of those requirements is literature monitoring and review—that is, systematic screening of scientific journals for documented or possible adverse drug reactions (ADRs)—the scope of which continues to expand. Importantly, shortcomings in this arena may be indicative of gaps in other areas of a company’s pharmacovigilance processes, or detract from an otherwise effective system that is already in place.
This paper will explore current and emerging literature monitoring and review requirements, which have global implications, and suggest five ways to make literature monitoring and review more comprehensive and, at the same time, more manageable.
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