課程資訊
課程名稱
醫材的臨床轉譯化與產業化
Clinical Translation and Industrialization of Biomaterials 
開課學期
109-1 
授課對象
工學院  化學工程學研究所  
授課教師
蔡偉博 
課號
ChemE7039 
課程識別碼
524 M1940 
班次
 
學分
3.0 
全/半年
半年 
必/選修
選修 
上課時間
星期五5,6,7(12:20~15:10) 
上課地點
綜502 
備註
化工選修課程。狄勝教授英語授課。蔡偉博教授中文授課。與狄勝合授
總人數上限:30人 
Ceiba 課程網頁
http://ceiba.ntu.edu.tw/1091ChemE7039_ 
課程簡介影片
 
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課程概述

Many pieces of a puzzle have to be assembled to enable the successful translation of a novel idea into the clinic for the benefit of patients. First, the idea needs to be tested in a research environment before protecting and communicating the results, for example in a patent and/or journal publication. At this stage, the research can attract the interest of clinicians and/or manufacturers, who can help to progress the testing through clinical trials before a product can be launched. This course will give an overview over some of the main pieces of the puzzle that play a role on the path from the “bench to the bedside”, and will equip students with first-hand, up-to-date knowledge regarding aspects such as the management of intellectual property, regulatory requirements and standards, clinical trials and strategies for effective communication in an interdisciplinary environment. Furthermore, the students will be taken through several examples of successfully translated biomedical products to highlight key issues and pitfalls. 

課程目標
Students gain a much sought-after understanding of the issues that are important for the successful translation of biomaterials research into the industrial world. 
課程要求
由於疫情的關係,Dr. Helmut Thissen無法來台上課,因此他的部分將改成同步與非同步混合線上課程。有一部分的內容,上課前在NTU COOL收看,上課的時間將以線上同步的方式討論其內容。 
預期每週課後學習時數
 
Office Hours
另約時間 備註: By appointment 
指定閱讀
待補 
參考書目
N/A 
評量方式
(僅供參考)
 
No.
項目
百分比
說明
1. 
Class Participation & Quizzes 
30% 
 
2. 
Final Written Report 
50% 
 
3. 
Final Oral  
20% 
 
 
課程進度
週次
日期
單元主題
第1週
09/18  Introduction to Biomaterials (Wei-Bor Tsai) 
第2週
09/25  Overview of Biocompatibility (Wei-Bor Tsai) 
第3週
10/02  Holiday 
第4週
10/09  Holiday 
第5週
10/16  Guest Speaker (James Lai) 
第6週
10/23  REGULATORY OVERVIEW FOR MEDICAL PRODUCTS (Wei-Bor Tsai) 
第7週
10/30  Translation of biomedical device technologies – The basics (Helmut Thissen) 
第8週
11/06  Intellectual property – How does this work and why is it important? (Helmut Thissen) 
第9週
11/13  Regulatory requirements in the context of biomedical devices (Helmut Thissen) 
第10週
11/20  Writing a successful project proposal (Helmut Thissen) 
第11週
11/27  Writing a convincing business plan (Helmut Thissen) 
第12週
12/04  Guest speaker 
第13週
12/11  Guest speaker 
第14週
12/18  Guest speaker 
第15週
12/25  Guest speaker 
第16週
01/01  Holiday 
第17週
01/08  Final presentation 
第18週
01/15  期末考週