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Online

May 15, 2017 12:00 PM - May 18, 2017 1:30 PM

Basics of the IND

Back to Agenda

Part 4

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

The IND In Detail - Additional Topics

  • Additional Requirements for Biologics and Biotechnology-derived Products
  • Assembly and Submission of an Original IND
IND Amendments and Maintenance
  • Amendments to the IND
  • Annual Reports
  • Non-standard INDs
  • IND Administrative Actions
Special Regulatory Considerations for Development
  • Special Protocol Assessment
  • Special Development Pathways
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