Head of Regulatory and Clinical Affairs within BSI Healthcare
BSI醫療法規和臨床事務負責人
Certification manager at BSI’s German Notified Body EUROCAT
BSI下屬德國公告機構EUROCAT發證經理
基本介紹
- 外文名：Gert W. Bos
- 職務：荷蘭KEMA和TNO並擔任醫療器械的首席發證經理
講師介紹,授課經歷, 教育經歷,
講師介紹
He acts as chair of the Brussels-based Notified BodyAssociation TEAM-NB, is vice-chair of the Medical Notified Body forum NB-Med inBrussels, and participates in the Notified Body Recommendation group(NBRG), the Clinical Investigation andEvaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEGworkgroups on animal tissue, on MRA’s, e-labeling, EUDAMED and on IVD’s. He isa member of the RAPS advisory committee, and one of the founders of the RAPSDutch chapter in his home country The Netherlands.
他是布魯塞爾公告機構協會TEAM-NB的主席、醫療公告機構論壇NB-MED的副主席；廣泛參與各類組織的活動，包括：公告機構建議組（NBRG）、臨床研究和評估組（CIE）、醫療器械專家組（MDEG）及其動物源、MRA、E-labeling、EUDAMED和IVD工作組。他同時還是RAPS（法規事務專家協會）的建議委會員成員及其荷蘭分會的創始人。
授課經歷
Gert has developed and delivered numerous presentationsat international conferences on e.g. revising EU legislation for devices,Compliance to EU MDD and IVD, Risk Management, Clinical Evaluations andInvestigations, Combination products, animal tissue directive, meetingessential requirements with harmonised standards, Post Market Surveillance andVigilance, Asian regulatory overviews, and best practice communications withNotified Bodies.
他撰寫了並在各類國際會議上發表了很多有關以下課題的演講，例如：歐盟器械法規變革、歐盟MDD和IVD法規的符合性、風險管理、臨床評估和研究、複合產品、動物源指令、符合協調標準的基本要求、售後監督和警戒、亞洲法規概覽及與公告機構溝通最佳實踐等課程。
教育經歷
Gert earned his PhD atTwente University of Technology,Enschede, the Netherlands, on a research project focusing on the improvement ofthe patency of small diameter vascular grafts using early tissue engineeringconcepts of animal proteins, growth factors and human tissue.
Gert的專業背景為醫藥及醫療器械的開發，他從荷蘭恩斯赫德的特文特大學（Twente University ofTechnology）獲得博士學位，研究課題為改善使用早期組織工程學概念的動物蛋白、生長因子和人體組織的小口徑血管植入物的通暢性。
Subsequently he spentfour years a position as researcher at Utrecht University, faculty ofPharmaceutical Sciences, on projects involving Biodegradable self-assemblingpolymeric systems for the controlled delivery of drugs and on therapeuticvaccines for chronic hepatitis B. The majority of this work was focused onpreclinical animal studies.
其後四年在荷蘭烏德勒支大學（Utrecht University）醫藥科學學院擔任研究員，主攻項目包括受控給藥用可生物降解自組裝聚合物系統和慢性B肝的治療疫苗。該工作的主要內容是臨床前動物研究。
Next, he held forthree years a position as business developer at the pharmaceutical developmentcompany OctoPlus B.V., Leiden, The Netherlands. In these positions he published16 scientific papers, numerous technical papers and wrote chapters ofscientific books.
之後三年他在荷蘭萊頓製藥開發公司OctoPlus B.V.的業務開發崗位上發表了16篇科學論文，數篇技術文檔並撰寫了一些科學書籍的部分章節。
For the following 7years he held 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.
此後七年，他就職於荷蘭KEMA和TNO並擔任醫療器械的首席發證經理。
