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Bethesda North Marriott Hotel and Conference Center

Feb 25, 2014 8:25 AM - Feb 26, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Information Management 2014

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Session 8B: Tools and Technology Track - US Module 1 Update and Implications

Session Chair(s)

Dominique Lagrave, PharmD

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)

Douglas Kent

AdPromo eCTD Submissions: Considerations & Communication

Douglas Kent

Janssen R&D, RIM, United States

Manager

Mark A. Gray

eCTD Module 1 Update

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

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