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

来源：

Pharmaceutical Medicine | 2008年 / 22卷 / 6期

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

页码：355 / 358

页数：3

共 6 条

[1]

Kundiiev YI(2008)Developing national systems for ethical review in Eastern Europe and Central Asia: legitimacy and responsibility Pharm Med 22 285-7

[2]

Vitte PN(2001)regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Off J L121 34-44

[3]

Chaschin N(2008)Clinical trials of pharmaceutical products in Ukraine: Meeting Report from the First National Scientific and Practical Conference Pharm Med 22 315-6

[4]

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[5]

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[6]

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