一、課程說明
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<br>The aim of this course is to introduce the knowledge of US FDA regulation on 
<br>drugs, biologics, medical devices, and other product classifications such as 
<br>combination products and human cell and tissue products (HCT/Ps).
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<br>本課程目的主要介紹美國FDA對藥品、生物製劑、醫療器械與其他分類產品如組合產品與人體細胞組
<br>織產品的相關生技醫藥器械專業法規知識。 
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<br>二、指定用書
<br>無
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<br>三、參考書籍
<br>Fundamentals of US Regulatory Affairs, 8th edition
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<br>四、教學方式
<br>Lectures and class discussion/participation
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<br>五、教學進度
<br>Section I: General information
<br>-	FDA and Related Regulatory Agencies
<br>-	History of Food, Drug and Cosmetic Laws
<br>-	Overview of Drug, Biologic and Device Regulatory Pathways
<br>-       FDA communications and Meetings
<br>-       Preparing for Key FDA Meeting and Advisory Committee Meetings
<br>-       Good Laboratory Practice Regulations
<br>-       Clinical Trials: GCPs, Regulations and Compliance
<br>-       Current Good Manufacturing Practice and Quality System Design
<br>Section II: Drugs
<br>Section III: Medical devices
<br>Section IV: Biologics
<br>Section V: Other product classifications
<br>-	Combination products
<br>-	Human cell and tissue products
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<br>六、成績考核
<br>(I) Mid-term Exam includes the US regulatory knowledge of strategic planning 
<br>domain, pre-approval domain, approval domain, and post-approval domain (50%)
<br>(II) Final Exam: Group presentation (50%)
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<br>七、講義位址  http://
<br>E-learning