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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2020
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| 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 |