基本素養 Basic Literacy

人文素養
Spirit of Humanism
公民素養
Civic Concern
社會關懷
Social Concern
國際視野
Global Vision

核心能力 Competence

專業與跨域能力
Professional and Interdisciplinary Abilities
思考與判斷能力
Critical Thinking Abilities
良好的溝通能力
Language Proficiency and Communication Abilities
創新與領導能力
Innovative and Leadership Abilities

課程概述 Course Description

建教個案安排學生實際參與藥物發展之各階段工作, 包括investigator brochue(試驗主持人手冊)之撰寫,IND(試驗中新藥之申請,IRB(人體試驗委員會)同意臨床試驗之執行,臨床藥動之分析,NDA dossier 之撰寫等之部分。
CASE TRAINING IN DRUG DEVELOPMENT AND POST-MARKETING STUDIES

課程學習目標 Course Objectives

  • 安排學生實際參與藥物發展之各階段工作
  • investigator brochue(試驗主持人手冊)之撰寫
  • 試驗中新藥之申請,IRB(人體試驗委員會)同意臨床試驗之執行
  • 課程進度 Progress Description

    進度說明 Progress Description
    1N/A
    2Introduction
    3各期臨床試驗在藥品開發的角色與目的 (郭慧媛經理 順天醫藥)
    4各期臨床試驗在藥品開發的角色與目的
    5N/A
    6新藥臨床開發第一步-Investigational New Drug (IND) (李純純總經理 維州生技)
    7臨床試驗計畫書內容與設計考量/ Protocol development (邱怡君處長QPS昌達生化科技公司)
    8N/A
    9優良藥品試驗準則 (ICH GCP); CRA (臨床試驗監測員)之角色與工作:從啟動試驗至結案(葉子綺 順天醫藥)
    10Quality Assurance of Clinical Trial (游梓瑋經理 華鼎生技)
    11Quality Assurance of Clinical Trial
    12Quality Assurance of Clinical Trial
    13GCP Inspection(劉文婷經理 台灣百靈佳殷格翰)
    14CRO Role in Biotech and Pharmaceutical Development (柯光達副總經理 維州生技)
    15臨床試驗藥局簡介
    16臨床試驗藥局簡介
    17臨床試驗藥局簡介
    18心得報告繳交
     以上每週進度教師可依上課情況做適度調整。The schedule may be subject to change.

    課程是否與永續發展目標相關調查
    Survey of the conntent relevant to SDGs

    本課程與SDGs相關項目如下:
    This course is relevant to these items of SDGs as following:
    • 健康與福祉 (Good health and Well Being)

    有關課程其他調查 Other Surveys of Courses

    1.本課程是否規劃業界教師參與教學或演講? 是,約 6 次
    Is there any industry specialist invited in this course? How many times? Yes, about 6 times.
    2.本課程是否規劃含校外實習(並非參訪)? 否
    Are there any internships involved in the course? How many hours? No
    3.本課程是否可歸認為學術倫理課程? 否
    Is this course recognized as an academic ethics course? In the course how many hours are regarding academic ethics topics? No
    4.本課程是否屬進入社區實踐課程? 否
    Is this course recognized as a Community engagement and Service learning course? Which community will be engaged? No