Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 18: Spontaneous Case Report

Session Chair(s)

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.

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 18: Spontaneous Case Report

Session Chair(s)

Jill W. Buckley, PharmD

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