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Sheraton Philadelphia University City

Oct 14, 2019 7:45 AM - Oct 16, 2019 4:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.

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Session 20: Spontaneous Case Report

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

Attendees will review a spontaneous case report for a fictitious marketed product to determine seriousness, expectedness and regulatory reporting requirements.

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