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This course will provide an overview of epidemiologic principles as they apply to pre- and post-marketing safety surveillance and risk management. Topics to be covered include: study designs for observational (non-interventional) studies, including case-control and cohort studies and studies of disease natural history; database studies and “big data”; and fundamental methods of analysis. Examples of epidemiologic approaches to meeting regulatory requirements for post-marketing studies will be reviewed.

Learning objectives

At the conclusion of the course, participants should be able to:
  • Apply epidemiologic methods to drug/biologic/device safety surveillance
  • Recognize the role of epidemiology during product development
  • Explain the advantages and limitations of various study designs, and make recommendations about the best approaches to address safety analyses
  • Determine how to identify the best data source(s) for answering a regulatory requirement for post-marketing surveillance
  • Describe sources of “big data” and their value in safety surveillance and risk management