Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness

Background: Pharmacovigilance (PV) inspections are critical regulatory assessments that evaluate the robustness and compliance of a company’s drug safety system. Despite their significance, there is limited published guidance on how organizations—particularly Medical Safety functions—can prepare ope...

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Bibliographic Details
Main Authors: Tarek A. Hammad, Sasan Sabrdaran, Hesham Aboshady, Raquel Rogers, Jean-Marie Heim, Kim Bullano, Tatiana Ishida
Format: Article
Language:English
Published: SAGE Publishing 2025-08-01
Series:Therapeutic Advances in Drug Safety
Online Access:https://doi.org/10.1177/20420986251363378
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