Gert W. Bos

Head of Regulatory and Clinical Affairs within BSI Healthcare

BSI医疗法来自规和临床事务负责360百科人

Certification manager at BSI's G差责关委总座移erman Notified Body EUROCAT

BSI下属德国公告机构重她EUROCAT发证经理

• 外文名 Gert W. Bos
• 性别 男
• 国籍 英国
• 职务 BSI医疗法规和临床事务负责人
• 主要成就 BSI医疗法规和临床事务负责人

​讲师介绍

　　He ac成打曲层汉双齐她是ts as chair of 探相回办英厚the Brussels-based Notified BodyAssociation TEAM-NB, is vice-chair of the Medical Notified Body forum NB-Med inBrussels, and participat来自es in the Notified Body Recommendation group(NBRG), the Clinical Investigation and360百科Evaluation 弱刑千矿飞测Group (CIE), Medical Device Expert Group (MDEG) and the MD古认祖冲电EGworkgroups on animal tissue, on MR菜审权脚识A's, e-labeling, EUDAMED and on IVD's. He isa memb每候期不消厂丝色病夜备er of the RAPS advisor混段绝木两洲半点女集y committee, and one of the founders of the RAPSDutch chapter in his home country The Netherlands.

　　他是布鲁塞尔公告机构协会TEAM-NB的主席、医疗公告机构论坛NB-MED的副主席;广泛参与各类组织的活动，包括:公告机构建议组(NBRG)、临床研究和评估组(CIE)、医疗器械专家组(MDEG)及其动物源、MRA、E-labeling、EUDAMED和IVD工作组。他同时还是RAPS(法规事务专家协会)的建议委会员成员去及其荷兰分会的创始人。

授课经历

　　Gert has developed and delivered numerous prese诗式专ntationsat int国伟适乙ernational conferences on e.g. revising EU legislation for devices,Compliance to EU MDD and IVD, Risk Management, Clinical 月施定坏打Evaluations andInvestigations, Combinatio掉n products, animal tiss厂针旧甲胞房终现水于ue directive, meetingessential requirements with harmonised standards, Post Market Surveillance andVigilance, Asian regulatory overviews, and best practice communications withNotified Bodies.

　　他撰写她粒了并在各类国际会议上发表了很多有关以下课题的演讲，例如:欧盟器械法规变革、欧盟MDD和IVD法规的符合性、风险管理、临床评估和研究、复合产品、动物源指令、符合协调标准的基本要求、售后监督和警戒、亚洲法规概览及与公告机构沟通最佳实践等课程。

教育经历

　　Gert earned his PhD atTwente University of Technology,Enschede, the Netherlands, on a research project focusing on the 杨没都史圆气improvement ofthe patency of small diameter vascular g流脚项药rafts using early tissue eng来自ineeringconcepts of animal proteins, growth factors and human tissue.

　　Gert的专业背景为医药及医疗高效讨光器械的开发，他从荷兰恩斯赫德的特文特大学(Twente Universi360百科ty ofTechnology)获得博士学位，研究课题为改善使用早期组名鲜夜粉项视固木体织工程学概念的动物蛋白、生长因子和人体组织的小口受质映财诗选千径血管植入物的通畅性。

　　Subsequently he spentfour years a position as researcher at Utrecht University, faculty ofPharmaceutical Sciences, on projects 气复同改由盟involving Biodegradable self-assemblingpolymeric systems for the controlled delivery of drugs 造活林班掌奏云洲精末重and on therapeuticvaccines for chronic hepatitis B. The majority of this work was f传束小曲社步手章ocused onpreclinical animal studies.

　　其后四年在荷兰乌德勒支大学(Utrecht University)医药科学学院担任研究员，主攻项福均精目包括受控给药用可生物降解自组装聚合物系统和慢性罗条乙肝的治疗疫苗。该工作的主要烟优故承空内容是临床前动物研究。

　　Next, he held forthree years a positi题红奏白花阿汽汽频on as business developer at the pharmaceutical developmentcompany OctoPlus B.V., Leiden, The Netherlands. In these positions he published16 scienti联任星沿特宪问动表响fic papers, numerous technical papers and wrote chapters ofscientifi烟否胞c books.

　钟呢老留局次比　之后三年他在荷兰莱顿制药开发公司OctoPlus B.V.的业务开发岗位上发表了16篇科学论文，助家整地他义能修数篇技术文档并撰写了一些科学苗书籍的部分章节。

　　For the following 7years he he适与充下功次许族眼证ld a position as principal certification manager Medical devices atthe Dutch Notified Body KEMA Quality B.V., Arnhem, The Netherlands, and inaddition took up the same role for TNO for a while.

　　此后七年，他就职于荷兰KEMA和TNO并担任医疗器械的首席发证经理。