将质量文化转化为临床研究行为:扩大临床开发质量框架
Michael Torok1, Leslie Sam2, Jennifer Hebert3
1Global Head of Quality Assurance Programs at Roche/Genentech, 1 DNA Way, Suite 258A, South San Francisco, CA, 94080, USA. torok.michael@gene.com.
Therapeutic innovation & regulatory science
|February 7, 2024
概括
国际协调理事会 E8 准则修订1 (ICH E8 准则修订1) 促进质量文化. 本研究确定了关键的推动因素,并为临床研究组织提供成熟度模型,以评估和增强其质量文化.
科学领域:
- 临床研究 临床研究
- 制药品质量管理 制药品质量管理
- 监管科学 监管科学
背景情况:
- 国际协调理事会 E8 准则修订1 (ICH E8 准则修订1) 强调建立质量文化.
- 这包括重视批判性思维和关于质量关键要素的开放对话.
- 生物制药行业的利益相关者正在积极寻找切实可行的实施策略.
研究的目的:
- 解构使质量文化成为可能的基本要素.
- 为临床研究组织内可视化和评估质量文化提供成熟度模型.
- 为衡量和发展质量文化提供工具.
主要方法:
- 分析ICH E8(R1) 准则对质量文化要求的分析.
- 确定和定义关键的"支持者"对于批判性思维和主动对话.
- 开发成熟度模型,说明不同水平的质量文化.
主要成果:
- 质量文化的主要推动因素已被确定并解构.
- 成熟度模型为理解和评估质量文化提供了一个框架.
- 提供了实用示例和工具,用于组织自我评估和改进.
结论:
- 实施质量文化需要了解其核心组成部分和支持者.
- 成熟度模型是组织对其质量文化进行基准和推进的宝贵工具.
- 提出的指导和工具可以促进ICH E8的实际应用在临床研究中.
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