Short Course 1: Introduction to Pharmacoepidemiology

概要

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.

学習目的

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

Short Course 1: Introduction to Pharmacoepidemiology

概要

学習目的

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