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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。
Drug risk management runs through the entire life cycle of pharmaceuticals. Evaluation of risk and benefit of medicines is the core content of pre-market evaluation and post-market evaluation. Proactive and vigorous drug alerting activities are an important part of improving the drug regulatory level and ensuring public drug safety and effectiveness. International Society of Pharmacovigilance (ISoP) is an authoritative, independent and non-profit international academic organization. It is a professional academic platform for open and neutral sharing of experiences and knowledge in the international community. It aims to enhance the global science of pharmacovigilance Promote the development of pharmacovigilance and risk management technologies. This article describes the formation of its development, tasks and academic exchanges, etc., proposed ISoP for Chinese drug evaluation and pharmacy alert professionals to open a frontier of international drug alert technology and risk management strategy development window, it is worth China’s drug evaluation, drugs Vigilance and drug safety research, academic and medical institutions, pharmaceutical production and operation enterprises and government regulators full attention and active participation.