Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning

Background The European Medicines Agency Good Pharmacovigilance Practices (GVP) guidelines provide a framework for pharmacovigilance (PV) audits, including limited guidance on risk assessment methods. Quality assurance (QA) teams of large and medium sized pharmaceutical companies generally conduct a...

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Veröffentlicht in:	Therapeutic innovation & regulatory science 2021-01, Vol.55 (1), p.190-196
Hauptverfasser:	Zou, Min, Barmaz, Yves, Preovolos, Melissa, Popko, Leszek, Ménard, Timothé
Format:	Artikel
Sprache:	eng
Schlagworte:	Audit risk Dashboards Data transmission Drug Safety and Pharmacovigilance Impact factors Mathematical models Medicine Original Research Pharmaceutical industry Pharmaceuticals Pharmacology Pharmacotherapy Pharmacovigilance Pharmacy Quality assessment Quality assurance Quality control Risk assessment Statistical analysis Statistical models
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