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Session 8B: Tools and Technology Track - US Module 1 Update and Implications
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States
This session will focus on the eCTD Module 1 specifications. This session will include an overview of the Module 1 administration and submission information.
Speaker(s)
AdPromo eCTD Submissions: Considerations & Communication
Douglas Kent
Janssen R&D, RIM, United States
Manager
eCTD Module 1 Update
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
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