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Pharmacovigilance System Master File and Inspection Readiness

Prantika Khetarpal

Domain Consultant, Life Sciences

Pharmacovigilance System Master File is designed to summarize PV system

The Pharmacovigilance System Master File (PSMF) has a different name in different countries. Additionally, several countries have diverse PSMF requirements, while few others including the other ICH regions, do not mandate having a PSMF. This white paper discusses the requirements for PSMF maintenance, its various components, and how to have an inspection ready PSMF.

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