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Sheraton Boston Hotel

2017 年 08 月 14 日 8:00 上午 - 2017 年 08 月 15 日 3:30 下午

39 Dalton Street, , Boston, MA 02119 , USA

New Drug Product Development and Life Cycle Management

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Module 5: Phase 3 and Regulatory Review (continued)

Session Chair(s)

Courtland R. LaVallee, MBA

Courtland R. LaVallee, MBA

Executive Director, Project Management

Dynavax Technologies, United States

NDA Preparation
Review Clock
FDA Questions/Requests for Data
Label Negotiation
De-centralized Procedure
Mutual Recognition
Devices