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从欧洲监管机构发起的关于监管决策的研究中学习

Stefan Verweij1, Just Weemers2, Carla Jonker3

  • 1Dutch Medicines Evaluation Board, Utrecht, the Netherlands; Unit of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy, Groningen University, Groningen, the Netherlands.

Drug discovery today
|December 3, 2024
PubMed
概括

药物开发商在批准药物之前越来越多地使用现实世界的证据 (RWE). 监管机构发起的研究,得到了像DARWIN EU®这样的倡议的支持,对于监管决策至关重要,需要合作才能实现最佳的RWE产生.

关键词:
达尔文欧盟® 达尔文欧盟®关于 ENCEPPPP 的新闻现实世界的证据.临床研究研究临床研究观察性研究是一种观察性研究.进行监管决策.可复制性的可复制性研究协议研究协议.透明度 透明度 透明度

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