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Managing a Pharmacovigilance Program
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Item Number: NWRR3004
A 12-page procedure that describes the management of the ongoing assessment of the benefit-risk profile of products. This assessment is based on the collection and evaluation of safety reports with the goal to prevent adverse events to the extent possible. Includes sponsor and CRO responsibilities; pharmacovigilance specifications, plan requirements, methods, and monitoring; and safety reporting and requirements, assessing safety reports, and safety data management. This document assigns responsibility for each step of the procedure and applies to all safety reports, regardless of their source, generated for products distributed within the US, Canada, and Europe.
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