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The Westin Boston Waterfront

Aug 17, 2016 7:30 AM - Aug 18, 2016 3:00 PM

425 Summer Street, Boston, MA 02210

New Drug Product Development and Life Cycle Management

Module 5: Phase 3 and Regulatory Review (continued)

Session Chair(s)

Eileen  Girten, MS

Eileen Girten, MS

Medical Writing Therapeutic Area Lead

Pfizer Inc, 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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