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Sheraton Philadelphia University City

Oct 23, 2017 7:30 AM - Oct 26, 2017 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 15: The NDA in CTD Format: Types of NDAs

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • Getting from the IND to the NDA
  • Considerations in Planning for the NDA
  • Study Data from Different Populations
  • Types of NDAs

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