(精编)Introduction to MedDRA MedDRA介绍教学课件.pptVIP

Introduction to MedDRAMedDRA介绍;Terminology requirements 对术语的要求;Development Philosophy 编写原则; 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;用户群 规范机构 所规范企业 WHO（世界卫生组织） 其它;MedDRA分级;System Organ Clas