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为使从事体外诊断试剂注册工作的人员更好地理解体外诊断试剂注册申报的有关政策法规,熟悉和掌握注册申报有关审评技术要求和工作程序,提高注册申报工作的质量和效率,国家食品药品监督管理总局高级研修学院定于6月在北京举办体外诊断试剂注册专题培训班。现将有关事宜通知如下:
一、培训对象
(一)企业、高等院校、科研单位和医疗机构等从事体外诊断试剂研发、生产以及注册工作的相关人员。
(二)医疗器械监管机构及技术支撑机构从事体外诊断试剂监管、检测、审评等工作的相关人员。
二、培训内容及师资
(一)体外诊断试剂注册申报资料要求
主讲人:董劲春(医疗器械技术审评中心审评六部副部长)
(二)体外诊断试剂说明书编写要求解读
主讲人:解怡(医疗器械技术审评中心审评六部)
(三)体外诊断设备注册申报资料要求
主讲人:吴传松(医疗器械技术审评中心审评六部)
(四)体外诊断试剂产品技术要求编写常见问题汇总及分析
主讲人:陈亭亭(医疗器械技术审评中心审评六部)
(五)体外诊断产品注册申报资料常见问题汇总及分析
主讲人:刘容枝(医疗器械技术审评中心审评六部)
(六)体外诊断产品注册单元划分要求解读
主讲人:何静云(医疗器械技术审评中心审评六部)
(七)体外诊断试剂临床试验基本要求及常见问题解析
主讲人:吕允凤(医疗器械技术审评中心审评六部副部长)
三、培训时间和地点
培训时间:2018年6月26日报到,27日—28日培训
培训地点:北京市
四、其他事项
(一)培训班为期三天(含一天报到,二天培训),具体培训地点将于开班前5天另行通知,也可登录高级研修学院网站(www.cfdaied.org)查询。
(二)本次培训将邀请国家食品药品监督管理总局医疗器械技术审评中心相关领导及审评专家主讲。培训结束后,由国家食品药品监督管理总局高级研修学院颁发结业证书。
(三)培训费2200元(含培训、资料、文具及培训期间两天的午餐费用),可提前汇款至高级研修学院,也可报到时刷卡或现金交纳。培训期间食宿可由会务组统一安排,费用自理。
(四)报名办法:
1.微信报名:扫描培训通知右下方二维码进行报名;
2.网络报名:登录学院网站(www.cfdaied.org),进入招生消息,点击相关培训进行报名;
(五)联系方式
联 系 人:张武 王馨怡 侯晓晨
地 址:北京西站南路16号
电 话:010-63316158 63429266 63360959
传 真:010-63365032
咨询监督电话:400 900 1916
开户行:中国工商银行北京市太平桥支行
户 名:国家食品药品监督管理总局高级研修学院
帐 号:0200 0203 0901 4403 952
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)
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