AAI 843 - Regulatory Development of Animal Pharmaceuticals - FDA

Credits: 2

In this course, students will focus on the regulatory strategies that support product development and maintenance regulated by the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM).  This includes product development strategies based on clinical and nonclinical data, key manufacturing and supply chain regulations, and post approval product life cycle management, including pharmacovigilance. Variances between food animal and non-food animal targets in developing regulatory strategies will be reviewed.  Special topics, current topics and FDA enforcement actions will be covered.  

 

Requisites:
Prerequisite: AAI 840, STAT 703

Typically Offered
Summer

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