課 程 概 述
Course Description

課程編碼
Course Code
中文課程名稱
Course Name (Chinese)
英文課程名稱
Course Name (English)
總學分數
Credits
總時數
Hours
6805055 生物科技產品品質安全與管理法規 The Introduction to Quality,Safety and Regulation of Biology 2.0 2
中文概述
Chinese Description
生物科技產業已是二十一世紀世界各國的重要產業,我國亦視生技產業為繼電子產業後的新興產業,然而生物科技產業與其他科技產業的差異,在於用於人體或具醫療用途的生技產品,除了品質管理外,更須考慮安全與效能,我國與世界各國對於生技產品大都以建置相當程度的法規環境,以有效的管理生技產品並確保人之安全。因此,對於生技產品特有的管理制度以及安全與效能等特殊需求若無正確的認識,將非常不利產業發展。 本課程將以疫苗、血液製劑、基因工程製劑、診斷試劑、人體細胞組織產品等目前已研發成熟與正發展中的生技產品為例,從產品設計、品質與製程管制、效能與安全評估、法規環境與管理制度到我國管理方式,以深入淺出的方式做完整的介紹,此外,課程中也將針對生技產業面臨的生物安全問題及其需要的設施、生技產業的挑戰與機會等議題,進行充分的講述與討論。透過此課程,期望學生建立在生技產品品質管理、製程管制、安全評估及產品登記等方面的基本概念,以培養生技產業目前極度缺乏的製程規劃人材。
英文概述
English Description
In the 21th century, the bio-technological industry has been the important industry in the world. It is also the most emergent sunrise industry following the electronics industry in Taiwan. The bio-technological industry is very different from the other technological industries. The biological products intended for human therapeutic use have to face the needs of safety and efficacy except product quality. Taiwan government and other countries have established the regulatory framework for biological products to ensure their safety and efficacy. Therefore, the realization of the management system for biological products is very useful to industry development. This course uses the examples of vaccines, blood products, recombinant DNA products, diagnostic devices and human cell and tissue-based products to introduce the design control, quality control, process control, evaluation for safety and efficacy and regulatory framework in Taiwan. The course also discusses the issues of fac

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