1、交流题目：医疗器械标准与检测
时间：2019年9月2日下午13:30
地点：先进制造楼副楼124会议室
报告人简介：
黄嘉华，教授级高工，享受国务院特殊津贴专家。任国家药品监督管理总局医疗器械分类技术委员会执行委员、中国生物医学工程学会有源器械标准化技术委员会主任委员、全国医用电器标准化技术委员会（TC10）副主任委员、全国医疗器械质量管理和通用要求标准化技术委员会（TC221）副主任委员、中国食品药品监管研究会医疗器械标准化专业委员会副主任委员、《中国医疗器械杂志》副主编、上海市生物医学工程学会副理事长。先后主持或参加国家科技部、省部级科研项目7项，并获得上海市科技进步二等奖2项。
Jiahua Huang, Professor of Engineering, enjoys the special allowance of the state council. Executive member of NMPA medical device classification technical committee. Director of the active devices standardization technology committee of China BME. Deputy director of the national medical appliances standardization technical committee (TC10), Deputy director of the national medical equipment general requirements for quality management and standardization technical committee (TC221), Deputy director of China's food and drug supervision institute of medical equipment standardization committee, Deputy director of ‘Chinese Medical Device’ Journal, Vice director of Shanghai BME. He has hosted or participated in 7 scientific research projects of the ministry of science and technology and provincial and ministerial level, and won 2 second prizes of Shanghai science and technology progress award.
2、交流主题：医疗器械产品注册要求
讲座时间：2019年9月3日下午13:30
讲座地点：先进制造楼副楼124会议室
报告人简介：
钱虹，就职于上海市食品药品监督管理局认证审评中心,现任医疗器械注册部一职。主要从事医疗器械产品注册技术审计工作。作为行业资深专家，钱虹行事低调，对工作热情饱满，多次受邀作为嘉宾出席各类大会。2018年09月25日,钱虹受邀参加了由商图信息BMAP在上海市长宁区延安西路2099号主办的《InnoCosme 2018第二届国际化妆品技术峰会》,并发表了精彩演讲。
3、交流题目：创新医疗器械新政
时间：2019年9月6日上午9:30
地点：先进制造楼副楼124会议室
报告人简介：
林峰，现任上海市药品监督管理局医疗器械注册处稽查专员。
2000年进入上海市药监局，曾从事食品、药品和医疗器械等多项监管工作，2009年任上海市食药监局医疗器械注册处副处长、2011年5 月至2019年5月任处长，负责上海市医疗器械注册管理和上市前监管相关工作。1987年毕业于第二军医大学药学系。2007年参加上海与香港政府公务员交流项目;2012年作为访问学者在美国乔治城大学法律中心访学半年。
联系地址:上海市宜山路728号705室，邮编:200233
Biography of Lin Feng
Mr. Lin Feng joined Shanghai Municipal Food and Drug Administration (SHFDA) 19 years ago, and is currently the Inspection Commissioner of Shanghai Medical Products Administration(SHMPA). Since he served as deputy director of Medical Device Registration Office of SHFDA in 2009 and director in 2011, Lin Feng has been engaged in the registration (filing) of medical devices and pre-market supervision in Shanghai for more than 10 years.
He received a Bachelor of Science in Pharmacy in 1987 from the Second Military Medical University. In 2007, he attended the 4th Shanghai-Hong Kong Exchange Program for Civil Servants. In 2012, he studied in the Law Center of Georgetown University as a visiting scholar for half a year.
Add: Apt.705,728 Yishan Road, Shanghai, China, 200233