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首页> 美国卫生研究院文献>The Open Orthopaedics Journal >Suppl 2: Tissue Engineering Stem Cells – An e-Governance Strategy
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Suppl 2: Tissue Engineering Stem Cells – An e-Governance Strategy

机译：补充2：组织工程干细胞–电子治理策略

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摘要

The rules of governance are changing. They are necessarily becoming more stringent as interventions offered to treat conditions carry unpredictable side effects, often associated with novel therapeutic vectors. The clinical relevance of this relates to the obligations of those involved in research, to ensure the best protection for subjects whilst encouraging the development of the field. Existing evidence supports the concept of e-Governance both in operational health research and more broadly in the strategic domain of policy formation. Building on the impact of the UK Comprehensive Research Network and recent EU Directives, it is now possible to focus on the issues of regulation for cell therapies in musculoskeletal science through the development of the Advanced Therapeutic Medicinal Products (ATMP) category of research products. This article reviews the framework that has borne this and the need for more detailed Virtual Research Integration and Collaboration (VRIC) systems to ensure regulatory compliance. Technology research and development plans must develop in close association between tissue engineering and treating clinicians. The scope of this strategy relates to the handling of human tissues the transport and storage of specimens in accordance with current EU directives and the Human Tissue Authority (HTA) regulations.
机译：治理规则正在改变。由于提供的用于治疗疾病的干预措施通常会伴随新的治疗载体带来不可预测的副作用，因此它们必须变得越来越严格。其临床意义涉及研究人员的义务，以确保对受试者的最佳保护，同时鼓励该领域的发展。现有证据在运营健康研究以及更广泛的政策形成战略领域中都支持电子政务的概念。借助英国综合研究网络和最新欧盟指令的影响，现在可以通过开发高级治疗药物产品（ATMP）类别研究肌肉骨骼科学中细胞疗法的监管问题。本文回顾了承载此问题的框架以及对更详细的虚拟研究集成与协作（VRIC）系统的需求，以确保合规性。技术研究和开发计划必须在组织工程学和治疗临床医生之间建立紧密联系。该策略的范围涉及根据当前的欧盟指令和人类组织管理局（HTA）法规处理标本的运输和存储。

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