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- 在支持新产品注册方面,CRS需要翻译注册资料的临床部分,回复注册管理部门对于临床部分的相关问题,为药品技术审评中心的审评会准备幻灯片,并进行演讲。As regards supporting new product registration, the CRS is required to translate clinical section of submission dossier, respond to Regulatory agency for clinical related queries, prepare slides and deliver presentations for CDE( Center of Drug Evaluation) Review Meeting as required.
- 仿制药品技术审评问题的研究Discussion on the Technical Evaluation for Generic Drug Application
- 中心heart
- 器械技术instrument technology
- 非器械技术Non-Instrumental Technique
- 探针,探子用于探查伤口或体腔的一种细长的可弯曲的外科医疗器械A slender, flexible surgical instrument used to explore a wound or body cavity.
- 浅析含有毒中药材的中药新药的技术审评Preliminary Analysis of Technological Evaluation of New Chinese Drugs Containing Contents of Toxic Chinese Medicinal Materials
- 国家药品监督管理局北京医疗器械质量监督检验中心Device Quality of State Drug A
- 关于目前中药新药注册管理及技术审评思考Considerations on Administration of Registration and Technical Evaluation of New Chinese Drugs Traditional
- 医疗器械法medical device act
- 三方审评tripartite review
- 抛接器械成为五项器械动作中最重要、最复杂、运用最广泛的共性动作,熟练准确的抛接技术是衡量运动员器械技术水平的重要指标。For the 5 items, large throws and catches are the most important and complicated apparatus movements, which is widely used in the exercises.
- 医疗器械局BMD; Bureau of Medical Devices
- 感官审评sensory evaluation
- 医疗器械报告Medical Device Report
- 药品统一审评Common drug review
- 医疗器械指令medical device directive
- 茶叶感官审评术语The terms of tea sensory tests
- 医疗器械证件credentials of medical instrument
- 共同药品审评(CDR)CDR