Content Contributor Melissa Byrn

Melissa Byrn, MS, MBE

Polsky Center for Entrepreneurship and Innovation, University of Chicago

Melissa is a strategic and innovative leader who accelerates the development, testing, and commercialization of cutting-edge medical technology. Melissa is currently the Assistant Dean for Clinical Research at the University of Chicago where she is responsible for leading the clinical trial enterprise across the UChicago Medicine health system. Melissa brings both industry and academic experience to her roles. Melissa teaches graduate courses at the University of Pennsylvania and the University of Chicago. She holds a graduate degree in Medical Ethics and Health Policy from the University of Pennsylvania and a graduate degree in Biomedical Informatics from the University of Chicago.

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FDA Inspections: From Site Preparation to Response FDA Inspections: From Site Preparation to Response
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Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.

FDA approved medical injection pens