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Category: Periodic Safety Update Reports (PSURs)

Periodic Safety Update Reports (PSURs) in Pharmacovigilance: A Complete Guide

Posted on April 28, 2025 digi By digi No Comments on Periodic Safety Update Reports (PSURs) in Pharmacovigilance: A Complete Guide

A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of a drug’s benefit-risk balance at defined intervals post-authorization. PSURs help regulators, sponsors, and healthcare providers understand the evolving safety profile of a medicinal product, ensuring that the benefits continue to outweigh the risks over time.
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Periodic Safety Update Reports (PSURs), Safety Reporting and Pharmacovigilance

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