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Sheraton Boston Hotel

14 ago 2017 7:30 a.m. - 17 ago 2017 5:00 p.m.

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 13: Reporting Adverse Events (AEs) During Clinical Trials

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

Definitions of Terms
IND Safety Reports
IND Annual Reports - Safety Information
Discontinuation of Studies for Safety Reasons

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