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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 14: The NDA in CTD Format: Types of NDAs

Session Chair(s)

Elliott Berger, PHD, MS

Elliott Berger, PHD, MS

President

ETB Regulatory Consulting, 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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