June 17 - June 21, 2019
1:30 p.m. – 5:00 p.m.
Course Number: 340.617.11
"Having multiple presenters with different areas of expertise was engaging. There was a good mix between introducing the necessary vocabulary, methods, and interpreting the results. The readings supplied were thought provoking." - Student, 2018
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.
Student Evaluation: Final exam
This course will prepare students to do the following:
Describe the process of drug development in the United States and articulate the criteria for marketing approval.
Explain the concept of risk management and distinguish among the different levels and types of programs.
Critically evaluate study designs used to understand the safety and effectiveness of medications.
Grading Options: Letter Grade or Pass/Fail
Prerequisites: Introductory epidemiology
Course Materials: Provided in class