School of Public Health

EPI 533 PHARMACOEPIDEMIOLOGY

EPI 533 Pharmacoepidemiology (3)

Overview of pharmacoepidemiology including drug development and approval; application of epidemiologic methods to study drug safety and effectiveness; exploration of the interplay between research and public policy; introduction to resources for information about drugs; introduction to pharmacology principles pertinent to pharmacoepidemiology. Prerequisite: Health Sciences graduate student; either EPI 511 or both EPI 512 and EPI 513. Offered: jointly with PHARM 533.

Spring 2018

Line Number Section ID Credits Days/Times Room/Bldg Instructor
00000A3.0Monday, Wednesday @ 10:30am - 11:50amN/ASusan R Heckbert
For a complete listing of Epidemiology courses, their elective categories, and when they are typically offered, please see the Epidemiology Course Planning Sheet

Additional Course Details

This course is required for PhD students in the Department of Pharmacy Pharmaceutical Outcomes Research and Policy Program, and is an elective for graduate students in the School of Public Health.  

Topics Covered

  • Drug approval process
  • Post-marketing surveillance
  • Pharmacology relevant to drug safety
  • Big data
  • Pharmacovigilence
  • Surrogate endpoints
  • Confounding by indication
  • Healthy user bias
  • Medication adherence
  • Non-inferiority study designs
  • Development of prognostic models
  • US drug safety system
  • Medication safety in pregnancy
  • Marginal structural models, propensity scores, inverse probability weighting
  • Pharmacogenomics    

Course Objectives

By the end of the course, you should be able to:

  1. Explain the US drug development and approval process, its strengths and limitations
  2. Define key pharmacology principles necessary for conducting pharmacoepidemiologic research
  3. Describe resources for information about drugs and drug effects  
  4. Explain research methods appropriate to pharmacoepidemiology
  5. Explain strengths and limitations of studies in the field  
  6. Describe the interplay between research and public policy

Course Format

Two sessions per week, informal lecture, discussion, or student presentations    

How You Will Be Evaluated

Grades will be based upon class participation and a term paper and oral presentation of that paper at the end of the quarter. There is no midterm and no final exam. You will write a short term paper on a pharmacoepidemiology topic of your choice.    

Contact the Instructor

Susan R Heckbert (heckbert@uw.edu)