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Online

Nov 01, 2017 12:00 PM - Nov 09, 2017 1:30 PM

Basics of the NDA

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Part 1: The NDA in CTD Format

Session Chair(s)

Karen K. Church, PhD

Karen K. Church, PhD

Principal

Coachella Valley Regulatory Group, United States

  • Getting from the IND to the NDA
  • Considerations in planning the NDA
  • Study data from different populations
  • Types of NDAs

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