課程資訊
課程名稱
藥物流行病學
Pharmacoepidemiology 
開課學期
108-2 
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/1082EPM7166_ 
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
另約時間 備註: Ms. Eva Huang 116330@ntuh.gov.tw, 02-3366-8691 
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/20
12/06/WC500129137.pdf

Guidelines for Good Pharmacoepidemiology Practices (GPP) --
http://www.pharmacoepi.org/resources/guidelines_08027.cfm 
指定閱讀
Regulatory guidelines 
評量方式
(僅供參考)
 
No.
項目
百分比
說明
1. 
Two sets of written critique of published articles 
50% 
2次作業(各25%) 
2. 
In-class presentation & participation of discussion 
20% 
 
3. 
Final examination OR Final report  
30% 
要考期末考的同學另訂時間 
 
課程進度
週次
日期
單元主題
第1週
03/02  Course overview, introduction (張家勳醫師) 
第2週
03/09  Medical product development and product life cycle 
第3週
03/16  Randomized trial and observational studies  
第4週
03/23  課程暫停一次 
第5週
03/30  Cohort studies 
第6週
04/06  Case-controls studies 
第7週
04/13  Case-crossover studies and self-controlled case series 
第8週
04/20  Meta-analysis for safety assessment 
第9週
04/27  Comorbidity measures and control for confounding  
第10週
05/04  Pharmacovigilance (黃薇伊組長) 
第11週
05/11  Safety surveillance, safety signal detection & refinement 
第12週
05/18  Health data and related ethics considerations 
第13週
05/25  Drug utilization studies
Time series analysis 
第14週
06/01  Pharmacogenomic
Epidemiology in medical product development 
第15週
06/08  Regulatory decisions and therapeutic risk management  
第16週
06/15  Benefit-Risk assessment
Real World Evidence