【醫材系列】IVD成功策略經驗分享 (一日精修班)

2019/06/01 (確定開班)
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單元主題
上午單元:如何找尋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/下午)
 
上午主題  09:30~12:30 (如何找尋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

 
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全日課程預排表  
Part 1 主題:如何找尋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
9:30-10:30 Introduction 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
10:30-12:00 Small 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
12:00~12:30 Wrap-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~ 14:30 Introduction 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
14:40~16:00 2.IVD Device License, Clearance and Approval (IVD - 各國主要產品認證成功關鍵)
•FDA, USAHealth CanadaCEFDA, Taiwan
•Others
Case Study:
Innovation Device 510(k) application
- Smartphone as IVD device
- SaMD
16:00~16:30 Q&A, and Net working  
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【講師簡歷】
 
1.Paul Kao (高興波)副總裁
Vice President, Business Development
Biosciences Group, GenScript
 
Paul has over 30 years of business and management experience in specialty chemical, life sciences and contract manufacturing. He is an experienced business professional in establishing international sales partnerships and distribution channels. With a background in helping startups and companies enter and thrive in competitive markets, he has demonstrated success as a Biotech-Life Sciences corporate leader.
 
Paul joined GenScript in 2014 and his current role is the Vice President of Business Development. He is responsible for partnerships, in-licensing, and strategic investments. Previously, Paul worked in various life science companies in sales, marketing, and management positions. Between 2007 and 2010, Paul was the General Manager, North Asia Pacific and Applied Markets Leads for Asia Pacific at Applied Biosystems (now a part of  Thermo-Fisher Scientific), where he was responsible for regional sales with P&L responsibility. From 1987 to 2000, he worked at Clontech (now a part of Takara) in several executive roles and helped the company establish international subsidiaries in UK, Germany and Japan, and intensive international sales channels in over 30 countries. He also established the management system and responsible for human resources function.
 
Paul obtained a B.A. degree in Chemistry from Tamkang University in 1976, and his MBA from Santa Clara University in 1988. He enjoys cycling and has competed biking tours in Taiwan, Germany, Japan, and Croatia. Paul now lives in San Francisco Bay Area.
 
2.Feng-Yu Lee (朱棻玉) 董事長
Chief Compliance Officer, iXensor Co., Ltd.
President, Elite BioMedical Consulting, Inc.


US Regulatory Affairs and Compliance Executive with over 32 years’ experience leading and directing Regulatory strategy for domestic and international clients.
Spearheaded US FDA and Health Canada approval and clearance of IVDD products, including: medical device regulation compliance, pharmaceutical /medical device combination product compliance, 510(k) clearance, Biological Application License and Health Canada Medical Device License Application.
 
【上課時間】2019/6/1 ,共1週,週六9:30-12:30 / 13:30-16:30
【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$5,200
早鳥優惠: 5/20前完成報名及繳費者,只要NT$ 4,800 元 (限時/限額:10人)
  以上費用包含餐點及講義費
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 【諮詢專線】02-77003883 分機11或 分機12 歡迎來電

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