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国际药物警戒学会简介与启示

张力   

  1. 北京中医药大学东方医院
  • 收稿日期:2017-03-21 修回日期:2017-04-01 出版日期:2017-04-25 发布日期:2017-04-25

A Brief Introduction of International Society of Pharmacovigilance and Experience Sharing

张力   

  1. Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
  • Received:2017-03-21 Revised:2017-04-01 Online:2017-04-25 Published:2017-04-25

摘要: 药品风险管理贯穿于药品整个生命周期,药品风险效益评估是药品上市前审评与上市后评价的核心内容,积极深入地开展药物警戒活动是提高药品监管水平保障公众用药安全有效的重要环节。国际药物警戒学会(International Society of Pharmacovigilance,ISoP)是权威、独立、非营利性的国际性学术组织,是国际范围内公开、中立分享经验和知识的专业学术平台,旨在提升全球药物警戒的科学性,促进药物警戒和风险管理技术的发展。本文介绍了其组建发展、任务和学术交流方式等内容,提出ISoP为中国药品评价及药物警戒专业人员开启了一扇了解国际药物警戒技术和风险管理策略发展前沿的窗口,值得中国药品评价、药物警戒和药品安全领域科研、学术及医疗机构、药品生产经营企业及政府监管人员的充分关注与积极参与。

Abstract: Drug risk management runs through the entire life cycle of the drug.The risk and benefit evaluation is the core in pre and post-marketing evaluation. Establishment of in-depth pharmacovigilance actively is essential to enforce the drug regulation and safe/effective use of medication.The International Society of Pharmacovigilance(ISoP) is an independent non-profit international academic authority. It is an open and impartial international academic platform for experience and knowledge sharing, which aims to advocate international pharmacovigilance scientifically, and promote the development of pharmacovigilance and risk management.This article introduces the ISoP′s establishment, development, objectives, tasks and the situation of the academic communication. ISoP has set up a professional platform for the sharing of experience and knowledge for people who engages in drug safety and pharmacovigilance in all countries. It opens a window to extend our understanding to the development of the international pharmacovigilance and risk management strategy. It merits great attention and active participation for Chinese professionals, such as researchers, healthcare professionals, industry, academic and the government regulators in the field of pharmacovigilance, drug safety and drug evaluation.