課程資訊
課程名稱
藥物流行病學
Pharmacoepidemiology 
開課學期
109-2 
授課對象
公共衛生學院  流行病學與預防醫學研究所  
授課教師
陳建煒 
課號
EPM7166 
課程識別碼
849 M0610 
班次
 
學分
2.0 
全/半年
半年 
必/選修
選修 
上課時間
星期一6,7(13:20~15:10) 
上課地點
公衛213 
備註
與張家勳合授
總人數上限:30人 
Ceiba 課程網頁
http://ceiba.ntu.edu.tw/1092EPM7166_ 
課程簡介影片
 
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課程概述

This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices) will be discussed. Examples of descriptive epidemiology studies, cohort studies, case control studies, intervention studies, and meta-analysis will be drawn from recent literature to illustrate the application of relevant methods and the challenges in post-marketing medical product assessment. Perspectives from research institutions, medical product manufacturers, and regulatory agencies will be presented. Related topics, including therapeutic risk management, safety signal detection and refinement, data sources and ethics considerations, will be discussed. Advanced methodology, such as that utilized to address confounding by indication and misclassification will be briefly introduced. 

課程目標
To know how the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices). 
課程要求
Attend lectures, class presentation, homework, and a term paper 
預期每週課後學習時數
 
Office Hours
 
參考書目
Optional textbook Strom, Kimmel, & Hennessy (eds). Textbook of
Pharmacoepidemiology, 2nd Edition. Sussex: Wiley, 2013

EMA Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-
authorisation safety studies, VIII Appendix 1. Methods for post-
authorisation safety studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
12/06/WC500129137.pdf

ENCePP Guide on Methodological Standards in Pharmacoepidemiology
http://encepp.eu/standards_and_guidances/methodologicalGuide.shtml

Guidelines for Good Pharmacoepidemiology Practices (GPP)
https://www.pharmacoepi.org/resources/policies/guidelines-08027/

Guidance for Industry and FDA Staff -- Best Practices for Conducting and
Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare
Data
https://www.fda.gov/media/79922/download
 
指定閱讀
待補 
評量方式
(僅供參考)
   
課程進度
週次
日期
單元主題
第1週
2/22  Course overview, introduction 
第2週
3/01  228紀念日 
第3週
3/08  Medical product development and product life cycle 
第4週
3/15  Cohort studies  
第5週
3/22  Case control studies 
第6週
3/29  Case-crossover studies and self-controlled case series 
第7週
4/05  兒童節及清明節 
第8週
4/12  Clinical trials and meta-analysis  
第9週
4/19  Comorbidity measures, bias, and confounding 
第10週
4/26  Pharmacovigilance 
第11週
5/03  Safety surveillance, safety signal detection & refinement 
第12週
5/10  Health data and related ethics considerations  
第13週
5/17  Drug utilization studies
Time series analysis
 
第14週
5/24  Pharmacogenomic
Epidemiology in medical product development
 
第15週
5/31  Regulatory decisions and therapeutic risk management 
第16週
6/07  Benefit-Risk Assessment
Real World Evidence
 
第17週
6/14  端午節