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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 20: Post-NDA Approval Regulatory Requirements

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

Post-NDA approval obligations
Postmarketing (Phase 4) requirements and commitments
Supplements and other changes to an approved application
Postmarketing reporting of adverse drug experiences
15-Day Alert Reports
NDA Annual Reports
NDA Field Alert Reports
Biologic Product Deviation Reports
Drug registration and listing

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