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Received:September 15, 2023 Published Online:June 20, 2024
Received:September 15, 2023 Published Online:June 20, 2024
中文摘要: 药品和医疗器械上市后研究是产品全生命周期管理的重要环节。本文在文献调研和专家咨询基础上,提出药械产品上市后研究的概念体系,即什么是上市后研究(What)、为什么要开展上市后研究(Why)、谁开展上市后研究(Who)、如何开展上市后研究(How)、上市后研究的目的和目标(Objective)的3WHO框架。
Abstract:Post-marketing research on medicines and medical devices is an important aspect of product lifecycle management. Based on literature research and expert consultation, this article proposes a conceptual system for post-marketing research of pharmaceutical and medical devices, which includes a 3WHO framework of what is post-marketing research(What), why should post-marketing research(Why) be conducted, who should conduct post-marketing research(Who), how to conduct post-marketing research(How), and the objective of post-marketing research (Objective).
文章编号: 中图分类号:R97 R197.39 文献标志码:A
基金项目:中国工程院战略研究与咨询项目(2022-HZ-10)
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