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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
- President and CEO
- Regulatory eSubmissions, LLC, United States
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)
IND eCTDs Production and Delivery Strategies from a Low Volume Emerging Biotechnology Company
Emily Hall
- Associate Director, Regulatory Operations
- ACADIA Pharmaceuticals Inc., United States
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
IND eCTDs Production and Delivery Strategies from an eCTD Publishing Services Provider
Daniel Offringa
- Principal Consultant
- eSub Solutions, United States
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