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Session Chair(s)
Joel Finkle
Industry Expert
Retired, United States
Learning Objective : Identify process and technical changes required by the new eCTD 4 standard; Plan the transition to the new standard; Analyze the costs and benefits of implementing the new standard.
Speaker(s)
FDA Perspective on RPS/eCTD 4
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Industry Perspective on RPS/eCTD 4
Olga Alfieri, MBA, MSC, RAC
Eisai Co., Ltd., United States
Senior Director, Global Submission Management & Operations
Vendor Perspective on RPS/eCTD 4
Joel Finkle
Retired, United States
Industry Expert
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