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...

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Detalles Bibliográficos
Autores principales: Zou, Min, Barmaz, Yves, Preovolos, Melissa, Popko, Leszek, Ménard, Timothé
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785557/
https://www.ncbi.nlm.nih.gov/pubmed/32804381
http://dx.doi.org/10.1007/s43441-020-00205-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785557/
https://www.ncbi.nlm.nih.gov/pubmed/32804381
http://dx.doi.org/10.1007/s43441-020-00205-4

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