課程資訊
課程名稱
藥物流行病學
Pharmacoepidemiology 
開課學期
106-2 
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210 
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/1062EPM7166 
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
待補 
預期每週課後學習時數
 
Office Hours
 
參考書目
peer-reviewed research articles, commentaries, and FDA & EMA regulatory documents
Optional textbook Strom, Kimmel, & Hennessy (eds). Textbook of
Pharmacoepidemiology, 2nd Edition. Sussex: Wiley, 2013
FDA Guidance for Industry -- Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf

EMA Guideline on good pharmacovigilance practices (GVP) Module VIII –
Post-authorisation safety studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf

Guidelines for Good Pharmacoepidemiology Practices (GPP) --
http://www.pharmacoepi.org/resources/guidelines_08027.cfm
 
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3週
3/12  第一組 
第4週
3/19  第二組 
第5週
3/26  第三組 
第7週
4/09  第四組 
第8週
4/16  第五組 
第9週
4/23  第六組 
第10週
4/30  第七組 
第11週
5/07  第八組 
第12週
5/14  第九組 
第13週
5/21  第十組 
第14週
5/28  第十一組