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Sheraton Boston Hotel

Aug 14, 2017 8:00 AM - Aug 15, 2017 3:30 PM

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
    • Centralized Procedure
  • De-centralized Procedure
  • Mutual Recognition
  • Devices

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