ENGRegulatory Science for Medicine
注意
❯
- 領域專長課程可能有先修科目或開放對象之限制，選課前請先到臺大課程網確認。
- 領域專長的施行學期若晚於畢業當學期，學生即使修習專長課程且成績及格，仍無法取得認證。
施行學期：111-1 主責單位：DEPARTMENT OF PHARMACY
基本資訊
主責教師
姓名
email
linchauchang@ntu.edu.tw
聯絡窗口
姓名
陳怡君
email
vitachen@ntu.edu.tw
學習目標
1. Through this program, students will be able to understand the definition and value of regulatory science for medicine, and to critically appreciate the underlying rationale of current regulatory frameworks.<br> <br>2. Through coursework and group discussions, students will be able to understand the interrelationships and respective roles of law, science, and public health within the field of regulatory science for medicine.<br> <br>3. Through coursework and research activities, students will be able to acquire and apply methods for identifying and accessing the latest domestic and international information related to regulatory science for medicine.<br> <br>4. Through coursework and research activities, students will be able to analyze the key challenges facing regulatory science for medicine, examine these issues from multiple perspectives, and propose evidence-based strategies to address them.
課程架構
修課指引
The Specialization Program in Regulatory Science for Medicine comprises four modules: Fundamental Courses, Theoretical Courses, Methodological Courses, and Applied Practice Courses. The curriculum includes six courses totaling 14 (or 13) credits (as shown in Figure 1): Regulatory Science-Drugs and Health and Pharmacy Administration and Pharmacy Law under Fundamental Courses; Regulatory Science for Drugs and Devices-Precision Medicine under Theoretical Courses; Clinical Trials under Methodological Courses; and Special Topics (or Special Topics (I)) and Intellectual Property Rights and Patent Law (or Intellectual Property Rights in the Pharmaceutical Industry) under Applied Practice Courses.<br>This curriculum is designed to first establish students’ foundational knowledge in regulatory science and related legal frameworks through the Fundamental Courses Regulatory Science-Drugs and Health and Pharmacy Administration and Pharmacy Law. It then extends to theoretical exploration through Regulatory Science for Drugs and Devices-Precision Medicine, focusing on benefit–risk considerations in the drug development process.<br>Subsequently, the Methodological Course Clinical Trials provides students with a clear understanding of the concepts, design, and legal–ethical requirements governing clinical trial implementation.<br>Finally, the Applied Practice Courses allow students to engage in in-depth study aligned with their interests and faculty research areas through Special Topics (or Special Topics (I)), and to examine issues related to intellectual property and innovation in the pharmaceutical sector through Intellectual Property Rights and Patent Law (or Intellectual Property Rights in the Pharmaceutical Industry). This includes the evolution of international intellectual property frameworks as well as the growing interconnection between emerging pharmaceutical industry development and intellectual property management.<br><br>Level 1<br>(1) Regulatory Science-Drugs and Health<br>(2) Pharmacy Administration and Pharmacy Law<br><br>Level 2<br>Regulatory Science for Drugs and Devices-Precision Medicine<br><br>Level 3<br>Clinical Trials<br><br>Level 4<br>(1) Special Topics/Special Topics (I)<br>(2) Intellectual Property Rights and Patent Law/<br>Intellectual Property Rights in the Pharmaceutical Industry
課程資訊 
修習課程說明
修習課程說明編號
課程識別碼
課程名稱
學分數
備註
【落日條款】
- 適用對象： 112-1 入學之學生。
- 適用範圍： 112-1 (含) 以前終止之領域專長，詳見首頁最新消息。
【修習課程說明】
- 取得本領域專長認證須修習英語授課之班次
- 英語授課之課程識別碼第 4 碼為 E