(上課中)【醫材系列】創新醫材開發之實戰策略、市場經驗與成功個案解析

2021/ 4/24 , 5/8,   5/15 共三週 每週六(09:30~12:30 / 13:30~16:30)
創新醫材開發之實戰策略、市場經驗與成功個案解析
(Medical Device :From ideation to commercialization )
【課程簡介】
疫情過後,創新醫材的國際主要市場正將復甦,本課程將從市場需求大勢切入,從實戰經驗及案例研析,來看如何將創新的構想商品化,把商務目標作為產品開發之依歸,並從法規策略、市場進入策略,盡職調查,授權談判等各面向,探討創新醫材產品生命週期經營管理實務及執行案例。
 
【學習目標】
  • Product development and product lifecycle management
  • Go to Market Strategy and Exit
  • Case Study 
【課程規劃專家】鄭淑玲 博士(Shuling Cheng ,PhD) / AliraHealth Partner    
  (曾任 益安生醫 策略長:負責集團策略、技術授權及企業合作,擁有超過二十年產品開發與技術授權經驗豐富)
【上課日期/時間】  4/24 , 5/8,   5/15 (週六) 09:30~16:30 午休: 12:30~13:30
 5/1 勞動節 未排課(停課一次) 共3週 (總時數:18小時)
【線上報名】我要報名(報名截止)
【上課地點/教室】台北市大安區復興南路一段390號11樓(捷運大安站-信義路口)

【課程預排表】 *海外講師採視訊教學 / 教室現場由課程規畫專家同步授課 (雙講師)
 第一天 4/24
  1. Innovation and Commercialization Strategy
  • Market Trend Overview
  • Innovative and Strategic Product Development
  • Case Demo
 
  1. Align Product Development with business objectives
  • Product Development and Innovation
  • Overview of Product lifecycle management
  • Case Study
 
 
第二天 5/8 
  1. Product Development and lifecycle management
  • Design Control
  • Regulatory strategy
  • Strategic Clinical study design & execution
 
  1. Case study
  • FDA audit Fail & Success
  • Clinical Trial Fail& success
  • Product Recall (Quality)

 第三天 5/15 
  1. Go to Market Strategy
  • Overview Market access
  • Business model and Exit strategy
 
  1. Transaction and Due diligence
  • Commercialization DD
  • Deal structure& Negotiation
  • Case Study
 【講師介紹】
1.鄭淑玲博士(Shuling Cheng)/AliraHealth Partner 高階醫材策略發展  
  曾任益安生醫策略長,負責集團策略、技術授權及企業合作,擁有超過二十年產品開發與技術授權經驗豐富。 
2. 黃遵翰 (Ted Huang) 高階醫材產品開發
現職:AZ Taiwan:  Patient-Centric innovation manager
3. Mary McNamara-Cullinane / AliraHealth 醫材法規
具 25年以上醫材法規實務經驗、專精於歐美PMAs 、510(k)s等高階醫材查驗登記審查送件,有170案以上核准成功經驗
 4. Christopher Rao/ AliraHealth  
 VP of Clinical Development of Alira Health Clinical. Chris has over 15 years of experience in clinical research, with proficiency in a wide range of indications including gastroenterology, oncology, supportive care, medical devices, and dermatology.  is the VP of Clinical Development of Alira Health Clinical.
 
5. Kenny Carberry
Associate Director, Clinical Development.
Kenny Carberry leads business development efforts and initiatives for early-stage healthcare companies. His background covers a wide array of indications across pharma, medical devices, and digital health.
 
6. Deepak Sahu (joined Alira Health's Germany office in March 2013)  
專精於MedTech及Digital Health 系統產品開發,輔導MedTech及Digital Health 公司進入市場,得到健康保險給付;協助Siemens,SAP等企業強化AI演算;另擅長影像處理傳輸及訊息加密技術

【課程總時數】18小時 (3天)

【課程費用】 
*非本會團體會員每人NT$15,000
*本協會團體會員價每人NT$12,500
*4/10 前須完成報名及繳費者可享優惠價 每人 NT$ 11,000 (早鳥限額)
*同公司 2人同時報名 可享優惠價 每人NT$ 11,000
以上費用包含餐點及講義費

【諮詢專線】02-27836028 分機11或分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權,如有變動將會提前通知)