2021CMEF展会同期论坛：《欧盟新规下医疗器械临床试验要求》

发布时间：2021-05-06

主办单位：深圳市卓远天成咨询有限公司
会议时间：2021年5月14日上午 09:00-12:00
会议地点：国家会展中心(上海) 会议区 M702会议室
参与人员：医疗器械企业负责人、法规专员、注册专员、品质经理、技术管理者代表等
参会费用：每家公司2人免费（因场地有限，医疗器械生产企业优先）

会议摘要：

欧盟新规EU2017/745 (MDR)和EU2017/746 (IVDR)分别对普通医疗器械和体外诊断器械的合规确认强调了需要立足于临床数据，而且要求临床数据能够支持临床证据。临床试验作为获得临床数据的最为直接和最有力的方式，在新规背景下，要求有了较大的变化。尤其对于高风险的器械，临床试验数据甚至就是必须的。哪些器械必须要做临床试验? 哪些器械必须要在欧盟进行临床试验？能否合理的避开临床试验，或者至少避开在欧盟进行临床试验是广大医疗器械同行的核心关切点。若必须在欧盟进行临床试验，有哪些选择、途径和需要考虑的因素？本次讲座将与您一起探讨这些问题，希望能在临床试验要求方面为您提供一些帮助。

The new EUregulations EU2017/745 (MDR) and EU2017/746 (IVDR) respectively emphasizemedical device’s compliance to be based on clinical data, and require clinicaldata to provide sufficient clinical evidence. Clinical trials, as the most direct and powerful way to obtain clinicaldata, have undergone major changes in the context of the new regulations.Especially for high-risk devices, clinical trial data are a must in order to becompliant with the regulations. Which devices must undergo clinical trials?Which devices must undergo clinical trials in the European Union (EU)? Whetherclinical trials can reasonably be avoided, or at least avoided being executedin the EU, is the core concern of the majority of medical device stakeholdersand fellows. If clinical trials must be conducted in the EU, what are theoptions, approaches and factors to be considered? This lecture will discussthese issues with you, and hope to provide you with some help in terms ofclinical trial requirements under new EU regulations.

会议内容：

时间

题目

主讲人/职务

主讲人单位

09:00-

12:00

欧盟新规下医疗器械临床试验要求

Clinical InvestigationRequirements of Medical Device Under EU New Regulations

赖少娟ShawnaLai / 技术总监

美国明尼苏达大学生物医学博士

深圳市卓远天成咨询有限公司
Shenzhen Joyantech Consulting Co., Ltd

专家简介：

专家简介：
	赖少娟 / Shawna Lai
	赖少娟，女，中南大学医学学士、硕士，美国明尼苏达大学生物医学博士。多项专利的共同发明人和持有者，广州市高层次人才，曾主持多项省级、国家级科研项目。具有多年医疗器械研发和法规经验，熟悉多国法规和临床试验。曾服务过Abbott，ALBION等企业。目前是深圳市卓远天成咨询有限公司技术总监。 Dr. Shaojuan Laiobtained her Bachelor and Master degree of Medicine from Central SouthUniversity, and achieved a PhD degree in biomedicine from University ofMinnesota-twin cities, USA. She is theco-inventor and co-owner of several patents and is one of the high tier talentsof Guangzhou. Dr Lai used to be the principal investigator of severalprovincial and national research projects. She has several years of experiencein medical device R&D and regulatory affairs. She is also familiar withdevice’s clinical trials in multiple countries. She ever served Abbott, ALBION,etc. Currently, she is the CTO of Shenzhen Joyantech Consulting Co., Ltd.

联系方式：

深圳市卓远天成咨询有限公司

地址：深圳市南山区西丽留仙大道众冠时代广场A座1713A-1715

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关于卓远天成：
深圳市卓远天成咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构，可为您提供各个国家或地区医疗器械上市注册、医疗器械质量体系审查等多种国际注册及认证的咨询/代理服务。

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