球球大作战嘉年华直播|球球大作战加速吐球软件|
2016年02月18日 星期四 23:57:08

掌握大中華市場脈動.亞洲專業華文生技產業月刊

Loading 活動

« All 活動

  • This event has passed.

生技產業深耕學院【醫材系列】IVD成功策略經驗分享 (一日精修班)

六月1日 09:30:00 - 16:30:00

NT6000
edm_bia_201904_ivd_fb

【醫材系列】IVD成功策略經驗分享

(一日精修班)早鳥優惠中

2019/6/1,週六
?



【課程名稱】【醫材系列】IVD成功策略經驗分享
【課程規劃專家】高興波(Paul Kao) / GenScript 業務開發副總、朱棻玉 /穎銳生醫顧問公司 董事長
【上課時間】2019/6/1 ,共1週,週六9:30-12:30 / 13:30-16:3030
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓)
【課程費用】非團體會員NT$6,000,協會團體會員NT$5,200
早鳥優惠:5/1前完成報名及繳費者,只要NT$ 4,800 元 (限時/限額:10人)費用包含餐點及講義費
【預約/報名】我要預約/報名
【諮詢專線】02-77003883 分機11或 分機12 歡迎來電

【單元主題】

★上午單元:如?#25569;?#23563;合作夥伴以拓展商機
(BD for IVD : Business Development and Commercialization for IVD )

★下午單元:如何充分掌握法規要點,以利取得產品認證
(IVD Regulatory Compliance and Device License)
(下午單元可攜帶智慧型手機體驗IVD相關應用)

【課程簡介】

上午主題 09:30~12:30 (如?#25569;?#23563;合作夥伴以拓展商機實務)
BD for IVD : Business Development and Commercialization for IVD
規劃專家暨講師: 高興波(Paul Kao) / GenScript 業務開發副總
任職: Vice President, Business Development Biosciences Group, GenScript
The global IVD market continues to change and evolve, and this continuing evolution of technology opens up new opportunities for companies. With these new opportunities come changing business development and product strategies. Selected companies with well-established laboratory developed tests (LDTs) are now developing in vitro diagnostic (IVD) kits that can be widely used at clinical laboratories. Some companies that initially developed PCR-based products are moving towards NGS based testing.

Many diagnostic companies in Taiwan are looking partners for opportunities in commercialization and licensing. However, as the IVD market size in Taiwan is relatively small (about 1% of WW market), it’s quite challenging to establish successful business partnerships with international IVD companies.

This workshop is designed to share the experiences among all participants and define the best way to identify new opportunities with international IVD companies/partners through a systematic Business Development (BD) processes

下午主題:13:30~16:30 (如何充分掌握法規要點,以利取得產品認證)
IVD Regulatory Compliance and Device License
規劃專家暨講師:朱棻玉 /穎銳生醫顧問公司 董事長
任職:Chief Compliance Officer, iXensor Co., Ltd.
President, Elite BioMedical Consulting, Inc.

This course will provide a comprehensive understanding of critical compliance and enforcement trends and the contextual relationship of policy and regulation.

You will learn about:
– The Critical Global Compliance Regulations and Product Licensing Programs for IVD Company
– The importance of IVD Device Compliance
– What is MDSAP
– Product Licensing Application Strategy
– Software as Medical Device (SaMD)

Case Study: (下午單元可攜帶智慧型手機體驗IVD相關應用)
Innovation Device 510(k) application
– Smartphone as IVD device
– SaMD

【全日課程預排表】

Part 1主題:如?#25569;?#23563;合作夥伴以拓展商機(上午)???
BD for IVD:?This Part is designed to share the experiences among all participants and define the best way to identify new opportunities with international IVD companies/partners through a systematic Business Development (BD) processes
9:30-10:30Introduction and Presentation: Paul Kao
規劃專家暨講師: 高興波(Paul Kao)/ GenScript業務開發副總
?Global IVD trend and Taiwan IVD market
?How to conduct business development (BD) to identify partnering opportunities
?Case studies: 2-3 IVD companies in?Taiwan and China
10:30-12:00Small group discussion (小組討論)/中場休息:15分鐘
?Share BD experience and identify challenges
?Identify the “Best approach”?for future BD process.
?Small group presentations
12:00~12:30Wrap-up and networking
12:30~13:30中午休息/午餐時間????????????????????????????????????????????????????????????????????????????????????
Part 2主題:如何充分掌握法規要點,以利取得產品認證(下午)
13:30~ 14:30Introduction and Presentation
規劃專家暨講師:朱棻玉 /穎銳生醫顧問公司?董事長
1.Regulatory Compliance for IVD? Company (如何掌握各國主要法規要求1hr)?
?Quality Systems (QSRs, IVDD and IVDR)
?Post-market Surveillance and Medical Device Reporting (eMDR)
?Labeling Compliance
?GCP, GLP, GDP
14:40~16:002.IVD Device License, Clearance and Approval (IVD –?各國主要產品認證成功關鍵)
?FDA, USA、Health Canada、CE、FDA, Taiwan
?Others
Case Study:
Innovation Device 510(k) application
– Smartphone as IVD device
– SaMD
16:00~16:30Q&A, and Net working ?

?報名參加 更多資訊?

明細:

日期:
六月1日
時間:
09:30:00 - 16:30:00
費用:
NT6000
活動 Categories:
, ,
活動 Tags:
,
網址:
https://bioedu.org.tw/course_detail_56

主辦人

生技產業深耕學院
電話:
+886 2 7700 3883 分機11、12
電子郵件信箱
bioedu@taiwanbio.org.tw
網址:
https://bioedu.org.tw/

地點

科技大樓
台北市大安區和平東路二段106號4樓 台灣 + Google 地圖

Copyright? 2019 環球生技投資股份有限公司. All rights reserved.

讀者服務電話:(02)2726-1065  時間:週一 ~ 週五 9:00 ~ 18:00

服務信箱:[email protected]

地址:110臺北市信義區松德路161號2樓之3, Taiwan

球球大作战嘉年华直播