Module 6

03/10/2024

Model for excellence in PV* Scientific basis of the protection of public health

High quality medical & scientific evidence

Outcome measures: audit or inspection

Culture of scientific development

Robust scientific decision-making

Tools for protecting Public health

Measurable public health benefit

* Adapted from Waller and Evans (2003)

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Organisation of the PV system

People ● PV scientists : Expertise applicable across the portfolio ● Safety physicians : Skills for patient safety are broadly applicable ● Epidemiologists & Statisticians : Sound benefit risk assessment Processes ● Quality Management System for the PV System – PV System Master File prepared by EU QPPV Office – Reduction in complexity of SOPs & Working Practices – Unified working practices & manuals with training and competency tests IT systems ● ARGUS v7.0.5 is the global safety database; ARGUS Affiliate is the country affiliate safety database; PSI application supports reporting by patients and HCPs; Literature screening is conducted using LiSA

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