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
105-1 
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
524EM1940 
班次
 
學分
全/半年
半年 
必/選修
選修 
上課時間
星期一5,6,7(12:20~15:10) 
上課地點
工綜207 
備註
本課程以英語授課。大學部及外校學生欲選修請洽老師領取授權碼(開學後)。與狄勝合開
限碩士班以上
總人數上限:20人 
Ceiba 課程網頁
http://ceiba.ntu.edu.tw/1051ChemE7039_ 
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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
本課程有國外教師Helmut Thissen負責一半的課程,由於配合他在台灣的行程,需要三次課程在晚上上課,9/19, 29, 26, 6 pm。學生必須配合上課。他上課的部分,以英文授課。 
預期每週課後學習時數
 
Office Hours
每週一 12:20~15:10 
指定閱讀
N/A 
參考書目
N/A 
評量方式
(僅供參考)
 
No.
項目
百分比
說明
1. 
Midterm Exam 
40% 
 
2. 
Final Project and Oral Presenation 
50% 
 
3. 
Class Participation 
10% 
 
 
課程進度
週次
日期
單元主題
第1週
9/12  Introduction to Biomaterials 
第2週
9/19  What is special about biomedical products? /Commercialization /Regulatory compliance
 
第3週
9/26  Clinical trials/Production /Quality control
Research vs. Development / Intellectual property  
第4週
10/03  Day off
 
第5週
10/10  National Day/ Holiday 
第6週
10/17  REGULATORY OVERVIEW FOR MEDICAL PRODUCTS  
第7週
10/24  Biological evaluation 
第8週
10/31  Research and Development in Pharmosa/甘霈 
第9週
11/07  高階植入式醫材創業經驗分享/廖俊仁 
第10週
11/14  NEXGENIA — a journey for smart reagent commercialization/James Lai 
第11週
11/21  Day off 
第12週
11/28  Midterm Exam 
第13週
12/05  敷料產品/陳柏仰 
第14週
12/12  Day off 
第15週
12/19  Day off 
第16週
12/26  Oral Presentation 
第17週
1/02  New year/ Holiday