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Sheraton Philadelphia University City

2017 年 10 月 23 日 7:30 上午 - 2017 年 10 月 26 日 5:00 下午

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 20: Post-NDA Approval Regulatory Requirements

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, 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