This course is designed to provide an overview of US and international safety surveillance, including the role of epidemiology and risk management, from both industry and FDA perspectives. This overview is not a "how to” course in completing adverse event forms for regulatory reporting.
•The role of epidemiology in safety surveillance
•Domestic and international safety surveillance
•Regulatory and industry perspectives on safety surveillance and epidemiology.
•The role of epidemiology in safety surveillance
•Domestic and international safety surveillance
•Regulatory and industry perspectives on safety surveillance and epidemiology.
