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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
Senior Project Manager, DSB, CBER
FDA, United States
Learning Objective : Integrate the new technologies. Plan for upcoming regulatory changes.
Speaker(s)
eCTD IV: It's Almost As Fun As Super Bowl XLIX
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Industry Perspective on eCTD v4.0
Boris D. Braylyan
Pfizer, Inc., United States
Senior Director, Regulatory Information Management
Steps to eCTD 4 Adoption
Joel Finkle
Retired, United States
Industry Expert