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Sheraton Boston Hotel

2017 年 08 月 14 日 8:30 上午 - 2017 年 08 月 16 日 3:45 下午

39 Dalton Street, , Boston, MA 02119 , USA

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 17: Individual Case Safety Reports

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will focus on individual case safety reports (ICSRs) for marketed products and will highlight various challenges. Topics include sources of data, data elements, best practices for follow-up, role of narratives and special situations including literature, pregnancy, lack of efficacy, product technical complaints, and legal cases.

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