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Department: Epidemiology
Term: Summer Inst. term
Credits: 2 credits
Contact: Ayesha Khan
Academic Year: 2013 - 2014
Course Instructor:
  • Sheila Weiss Smith

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

Learning Objective(s):
Upon successfully completing this course, students will be able to:
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
Evaluate the quality and limitations of a Pharmacoepidemiology study design by applying concepts unique to pharmaceutical exposures
Understand how the concepts of epidemiology are applied to design studies where pharmaceutical products are the exposure of interest

Methods of Assessment: Final exam
Location: East Baltimore
Class Times:
  • Mon 06/17/2013 - Fri 06/21/2013
  • Monday 8:30 - 12:00
  • Tuesday 8:30 - 12:00
  • Wednesday 8:30 - 12:00
  • Thursday 8:30 - 12:00
  • Friday 8:30 - 12:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail