School of Public Health


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.

Line Number Section ID Credits Days/Times Room/Bldg Instructor
This course is not offered during the current quarter. For more info, please see the Epidemiology Course Planning Sheet at the link below.
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 and discussion, and journal club    

How You Will Be Evaluated

Grades will be based upon class participation, 2 homework assignments, interactive in-class journal club review of two articles, group study design/protocol presentation, and a review paper written by each student. There is no midterm and no final exam.    

Contact the Instructor

Susan R Heckbert (