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从美国经验看药物警戒的加强:现行做法与未来机遇

Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities.

机构信息

Global Patient Safety Evaluation, Research & Development, Takeda Pharmaceuticals International Co., 300 Massachusetts Avenue, Cambridge, MA, 02139, USA.

Brunel Canada, Laval, QC, Canada.

出版信息

Drug Saf. 2021 Aug;44(8):843-852. doi: 10.1007/s40264-021-01078-8. Epub 2021 May 15.

Abstract

This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices concepts could be applied worldwide through the presentation of how three pillars of pharmacovigilance: (1) medical and scientific excellence, (2) operational and compliance excellence, and (3) knowledge sharing and experts development in the field could serve as a framework for the establishment of an efficient and successful global pharmacovigilance system.

摘要

本综述旨在从美国的经验出发,探讨加强药物警戒的当前实践和未来机遇。通过展示药物警戒的三个支柱(1)医学和科学卓越、(2)运营和合规卓越、(3)领域内的知识共享和专家发展如何可以作为建立高效、成功的全球药物警戒系统的框架,将最佳实践概念应用于全球。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f86/8123099/48c519ead450/40264_2021_1078_Fig1_HTML.jpg

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