一、課程說明(Course Description)
<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 the 
<br>key historical milestones leading to today's healthcare regulations, and (c) 
<br>calrify 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(c)全球
<br>生技醫藥與器械法規的一致化
<br>
<br>二、指定用書(Text Books)
<br>無
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<br>三、參考書籍(References)
<br>Fundamentals of International Regulatory Affairs (2nd edition)
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<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>Lesson 1: What Products areRegulated and Why
<br>Lesson 2: Overview of Regulatory Systems and Agencies in the US
<br>Lesson 3: Overview ofRegulatory Systems and Agencies in the EU
<br>Lesson 4,5,6: Student Presentation (Canada, Australia, Japan)
<br>*GHTF member states: US, EU, Canada, Australia, Japan
<br>
<br>Part II: Pharmaceuticals:
<br>Fundamentals of International Regulatory Affairs 
<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>Medical Devices: Definition and Life Cycles
<br>
<br>Fundamentals of International Regulatory Affairs 
<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 20 Active Implantable Medical Devices
<br>Chapter 21 Software
<br>Chapter 22 Postmarket Requirements 
<br>
<br>Part IV: Biologics:
<br>
<br>Chapter 23 High-Risk Products: Products Derived from Biotechnology
<br>Chapter 24 Advancement of Biosimilars Development
<br>Chapter 25 Vaccines
<br>
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<br>六、成績考核(Evaluation)
<br>Mid-term: Group Presentation (20%)
<br>Final Exam (80%)
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<br>七、可連結之網頁位址
<br>Regulatory Affairs Professionals Society
<br>http://www.raps.org/