一、課程說明(Course Desc<x>ription)
<br>The aim of this course is to introduce (a) the knowledge about why healthcare  
<br>regulations for medicinal products and devices were established (b) discover 
<br>the key historical milestones leading to today's healthcare regulations, and 
<br>(c) clarify the importance of global harmonization.
<br>
<br>本課程目的主要介紹(a)全球生技醫藥與器械法規的知識(b)全球生技醫藥與器械法規的發展歷史
<br>(c)全球生技醫藥與器械法規的一致化
<br>
<br>二、指定用書(Text Books)
<br>無
<br>
<br>三、參考書籍(References)
<br>Fundamentals of International Regulatory Affairs (2nd edition)
<br>
<br>四、教學方式(Teaching Method)
<br>Lectures and class discussion/participation
<br>
<br>五、教學進度(Syllabus)
<br>
<br>Part I Introduction to Global Healthcare Product Regulation
<br>Chapter 4 Good Clinical Practices
<br>
<br>Part II: Pharmaceuticals:
<br>Chapter 9 Premarket Requirements/Dossier Requirements
<br>Chapter 10 Authorization Procedures for Pharmaceutical Products 
<br>Chapter 11 Stability Test Requirements
<br>Chapter 12 Quality Systems and Inspection Processes—Pharmaceuticals
<br>Chapter 13 Generic Drug Products
<br>Chapter 14 Over-the-Counter Products (OTCs) 
<br>Chapter 15 Pharmaceutical Postmarketing and Compliance 
<br>
<br>Part III: Medical Devices:
<br>Introduction to Medical Devices: Definition and Life Cycles
<br>Chapter 16 Medical Device Premarket Requirements
<br>Chapter 17 Technical and Regulatory Requirements 
<br>Chapter 18 Device Quality Systems
<br>Chapter 19 In Vitro Diagnostic Medical Devices 
<br>Chapter 22 Postmarket Requirements 
<br>
<br>
<br>
<br>六、成績考核(Evaluation)
<br>Mid-term and final report
<br>
<br>
<br>七、可連結之網頁位址
<br>Regulatory Affairs Professionals Society
<br>http://www.raps.org/