Creating a National Infrastructure for Good Clinical Practice in Clinical Trials in Ukraine

被引:0
|
作者
Yurii I. Kundiiev
Peter N. Vitte
Vyctor G. Lyzogub
Alla Stepanenko
机构
[1] National Bioethics Committee of Ukraine,Clinical Trials Coordination and Control Board, State Pharmacological Center
[2] Information Centre on Bioethics,Institute for Occupational Health
[3] Ministry of Health,undefined
[4] Academy of Medical Sciences of Ukraine,undefined
关键词
Ethical Review; Good Clinical Practice; Medical Institution; Pharmaceutical Product; Bioethic Committee;
D O I
10.1007/BF03256732
中图分类号
学科分类号
摘要
This article examines the current Ukrainian approach to creating a national infrastructure for medicines advancement and human subjects protection through clinical trials based on good clinical practice (GCP). It explores the roles of the government, the healthcare society, ethics committees and industry in contributing to the development of a national infrastructure that contributes to national needs in health research as well as the global development of medicines.
引用
收藏
页码:355 / 358
页数:3
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