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Graduate Summer Institute of Epidemiology and Biostatistics


June 20 - June 24, 2016
1:30 p.m. – 5:00 p.m.
2 credits
Course Number: 340.617.11

Course Instructor:


Introduces students to pharmacoepidemiology, application of epidemiologic methods to study uses and effects of pharmaceutical products in human populations. In addition to the identification and quantification of new adverse events and risk factors, students also examine studies of disease natural history necessary to understand drug effects and studies of drug utilization. Covers the development up to and including the seminal Phase 3 clinical trials for approval, the regulatory process, and the use and design of Risk Evaluation and Management (REMS) programs to mitigate known risks; identification of new risks for marketed products, including both active and passive surveillance programs, and the application of data mining; databases and study designs used in pharmacoepidemiology; the decision-making process in pharmacoepidemiology using contemporary examples; and new and emerging developments in the field including the application of meta-analysis to answer safety questions, the saf

Student Evaluation: Final exam

Learning Objectives:

This course will prepare students to do the following:

Auditors Allowed: No

Grading Options: Letter Grade or Pass/Fail

Prerequisites: Introductory epidemiology

Course Materials: Provided in class