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Regulatory Submissions, Information, and Document Management Forum


Session 6 Track 4: IND eCTDs: Transition from FDA Appreciating to Requiring eCTD INDs

Session Chair(s)

Daniel  Orfe, MS

Daniel Orfe, MS

  • President and CEO
  • Regulatory Esubmissions, LLC, United States

FDA mandates delivery of all commercial INDs in eCTD format commencing May 5, 2018. Paper INDs will not be allowed. Waiting until the mandate could be calamitous. Emerging and Top Tier Pharma will provide IND eCTD publishing insights and strategies.

Learning Objective : 1) Gain an awareness of the various strategies available for commencing IND eCTD production for their organization and determine which deserve further investigate. 2) Acquire an appreciation of the regulations governing the delivery of INDs in eCTD format and with this knowledge become empowered to influence their enterprises to expeditiously take up production of IND eCTDs.

Speaker(s)

Emily  Hall

IND eCTDs Production and Delivery Strategies from a Low Volume Emerging Biotechnology Company

Emily Hall

  • Associate Director, Regulatory Operations
  • ACADIA Pharmaceuticals Inc., United States
Kevin  Tompkins, MBA

IND eCTDs Production and Delivery Strategies from a High Volume Organization

Kevin Tompkins, MBA

  • Senior Director, Global Submission Management
  • Bristol-Myers Squibb Company, United States
Daniel  Offringa

IND eCTDs Production and Delivery Strategies from an eCTD Publishing Services Provider

Daniel Offringa

  • Principal Consultant
  • eSub Solutions, United States
Gina  Ross

IND eCTDs Production and Delivery Strategies from an Integrated Regulatory Science and Solutions Provider

Gina Ross

  • Managing Director, Regulatory Submissions & Admin Ops, Regulatory Sciences
  • Cardinal Health, United States