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Session 7 Track 2 - eCTD v4 / RPS; Are you preparing for the transition to eCTD v4?
Session Chair(s)
Mark A. Gray
Senior Project Manager, DSB, CBER
FDA, United States
Learning Objective : Adapt to changes to submission standards Comprehend the RPS standard Recognise value of volunteering for standards development
Speaker(s)
eCTD 4 and the FDA: The Not So Young and Restless
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Planning for eCTD 4 Transition Success: Early Opportunities to Set the Course for eCTD 4 (Industry Perspective)
Olga Alfieri, MBA, MSc, RAC
Eisai Pharmaceuticals, United States
Senior Director, Global Submission Management & Operations
eCTD 4 and RPS - Scissors Cuts Paper Covers Rock
Joel Finkle
Retired, United States
Industry Expert
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