Introduction to MedDRA MedDRA介绍课件.ppt

copyright Huntley Consulting LLC 2004 Introduction to MedDRAMedDRA介绍 Kathryn Huntley Huntley Consulting, LLC 2004年11月 Terminology requirements 对术语的要求 International applicability国际通用性 Supported and used by both industry and regulators 为企业界和规范机构支持和使用 Broader coverage of health data 能涵盖比较广泛的健康数据 Increased specificity 分类更精细、更特异 Structure to support analysis and presentation 其结构利于数据的分析和发表 Centrally and externally maintained 可以从中心和终端维护 Compatible with IT systems and tools 与信息科技系统及工具兼容 Development Philosophy 编写原则 Based upon ANSI Z911 standard (American National Standards Institute standard for the development of a thesaurus) 基于ANSI Z911标准（美国国家标准局词典开发标准） Provided structure for development and future maintenance activities 其结构有利于词典的继续扩展及未来的维护 Chosen to ensure the product would support the use of information technology 确保词典能够支持信息科技的运用 Internationally recognized standard 使用国际认可的标准 ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药品注册技术规范国际协调会Created to make recommendations on ways to achieve harmonization in technical requirements for medicinal product registration in order to reduce or prevent redundant testing carried out during the research and development of new medicines该组织的创建是为了统一医用产品注册的技术要求，以减少或杜绝重复进行新药研发中的试验 MedDRA Med= Medical医学 D = Dictionary for词典 R = Regulatory规范 A = Activities活动 MedDRA的定义MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing and for data entry, retrieval, evaluation and presentationMedDRA使用的是临床上认可的、国际通行的、而且为各级规范机构和生物制药业广范使用的医学术语。在整个需要管理规范过程中都使用这些术语，从药物上市前到上市后；这些术语可以用于数据录入，数据调用，评估，和发表等方面。 Maintenance Organization Structure维护机构的组成 MedDRA分级 System Organ Class系统和器官分类 Highest level of the hierarchy SOC是MedDRA的多级结构的最高级别 SOCs identified by SOC按下列情况分类 Anatom