PREV 722 ADVANCED TOPICS IN PHARMACOEPIDEMIOLOGY
The purpose of this course is to engage students in the techniques of pharmacoepidemiology through case studies and by working through an actual drug safety investigation. Drug safety will be addressed in the context of science and the law through readings, debates, and discussions with invited guests from the FDA, a pharmaceutical company/consulting agency, and a law firm. Students will work together as an investigative team under the direction of the instructor. Using the Food and Drug
Administration's Adverse Event Reporting System database and the medical literature, students will work up the epidemiological characteristics of a drug safety signal. Based on the characteristics of the signal, the team will design a pharmacoepidemiological study to further evaluate the safety signal. Prerequisites: PREV 600, PREV 620, PREV 705/PHSR 704, or permission of the instructor.