QPPV, Governance & PSMF
Explore all topics, guides, and frameworks related to QPPV, Governance & PSMF.
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2- What Is a QPPV? Role, Legal Position and Pharmacovigilance Oversight The qualified person responsible for pharmacovigilance is the continuously available individual through whom an EU marketing authorisation holder maintains expert oversight of its pharmacovigilance system and medicinal-product safety profiles. This article explains the role from first principles, distinguishes QPPV oversight from operational work and corporate accountability, and shows how authority, information, decisions and evidence connect. Read Article →
- EU QPPV Requirements: Qualification, Location, Authority and Availability EU QPPV compliance is more than naming an individual. The marketing authorisation holder must establish an appropriately qualified, continuously available role that resides and operates in the Union, has adequate knowledge and support, can access the pharmacovigilance system and PSMF, and is positioned to exercise real authority. Read Article →