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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
ACADIA Pharmaceuticals Inc., United States
Associate Director, Regulatory Operations
IND eCTDs Production and Delivery Strategies from a High Volume Organization
Kevin Tompkins, MBA
Bristol Myers Squibb, United States
Executive Director, Regulatory Information & Submission Management
IND eCTDs Production and Delivery Strategies from an eCTD Publishing Services Provider
Daniel Offringa
eSub Solutions, United States
Principal Consultant
IND eCTDs Production and Delivery Strategies from an Integrated Regulatory Science and Solutions Provider
Gina Ross
Cardinal Health, United States
Managing Director, Regulatory Submissions & Admin Ops, Regulatory Sciences