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Sheraton Philadelphia Downtown Hotel

May 11, 2015 1:00 PM - May 13, 2015 5:00 PM

201 North 17th Street, Philadelphia, PA 19103

eRegulatory and Intelligence Annual Conference

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Session 6 Track 2: eCTD v4 / RPS; So Now We Have a Standard, How Do We Implement eCTD v4?

Session Chair(s)

Mark A. Gray

Mark A. Gray

Senior Project Manager, DSB, CBER

FDA, United States

Overview of the upcoming RPS standard replacing eCTD 3, including experience from regulators, vendors and industry sponsors. Plan for upcoming changes to the standard, and what work will be needed.

Learning Objective : Integrate the new technologies. Plan for upcoming regulatory changes.

Speaker(s)

Mark A. Gray

eCTD IV: It's Almost As Fun As Super Bowl XLIX

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

Boris D. Braylyan

Industry Perspective on eCTD v4.0

Boris D. Braylyan

Pfizer, Inc., United States

Senior Director, Regulatory Information Management

Joel Finkle

Steps to eCTD 4 Adoption

Joel Finkle

Retired, United States

Industry Expert

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