一、課程說明(Course Description)
<br>The aim of this course is to introduce (a) the knowledge about why healthcare regulations for medicinal products and devices were established (b) discover the key historical milestones leading to today's healthcare regulations, and (c) calrify the importance of global harmonization.
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<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)全球生技醫藥與器械法規的一致化
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<br>二、指定用書(Text Books)
<br>無
<br>三、參考書籍(References)
<br>Fundamentls of International Regulatory Affairs (5th edition)
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<br>四、教學方式(Teaching Method)
<br>Lectures and class discussion/participation
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<br>五、教學進度(Syllabus)
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<br>Part I Introduction to Global Healthcare Product Regulation
<br>Lesson 1: What Products areRegulated and Why
<br>Lesson 2: Overview of RegulatorySystems and Agencies in the US
<br>Lesson 3: Overview ofRegulatory Systems andAgencies in the EU
<br>Lesson 4: Overview ofRegulatory Systems andAgencies in Canada
<br>Lesson 5: Overview of RegulatorySystems and Agencies in Australia
<br>Lesson 6: Overview ofRegulatory Systems andAgencies in Japan
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<br>Part II: Medical Devices:Definition and Lifecycle
<br>Chap 12, 13, 14, 15
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<br>Part III: Drugs and Biologics: Definition and Lifecycle
<br>Chap 1, 2, 3, 4, 5, 6, 7, 8, 11
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<br>六、成績考核(Evaluation)
<br>Report and written exam
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<br>七、可連結之網頁位址
<br>Regulatory Affairs Certification (RAC)
<br>http://www.raps.org/