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 |
106-1 |
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 |
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學分 |
3.0 |
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 |
新401 |
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)。與狄勝合授 限碩士班以上 總人數上限:20人 |
Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/1061ChemE7039_ |
課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
課程大綱
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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 |
Because Dr. Helmut Thissen needs to teach his parts in a week, parts of classes have to be held in the evenings of 10/23, 24, 25,26 from 6 pm. |
預期每週課後學習時數 |
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Office Hours |
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指定閱讀 |
待補 |
參考書目 |
N/A |
評量方式 (僅供參考) |
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週次 |
日期 |
單元主題 |
第1週 |
9/11 |
Introduction to Biomaterials |
第2週 |
9/18 |
Biocompatibility |
第3週 |
9/25 |
9/25 No class (Homework 1 due)
9/30 Make-up day for 10/9 Biological Evaluation |
第4週 |
10/02 |
NEXGENIA — a journey for smart reagent commercialization/Prof. James Lai |
第5週 |
10/09 |
Holiday |
第6週 |
10/16 |
In vitro cytotoxicity tests/Regulatory overview for medical products |
第7週 |
10/23 |
5 sessions from Dr. Thissen
10/23 (class time) and the evenings of 10/23, 24, 25, 26 |
第9週 |
11/06 |
Regulatory overview for medical products |
第16週 |
12/25 |
Oral Presentation |
第17週 |
1/01 |
Holiday |
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