Short Course 1: Introduction to Pharmacoepidemiology

Overview

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

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Short Course 1: Introduction to Pharmacoepidemiology

Overview

Learning objectives

Be informed and stay engaged.