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Regulated Product Submissions and eCTD 4: The Path to Progress
Session Chair(s)
Joel Finkle
Industry Expert, Retired, United States
With HL7 standard approval, regulated product submissions (RPS) now move to International Organization for Standardization (ISO) approval prior to ICH Step 4 adoption as electronic common technical document (eCTD) 4.0. Listen to vendor, agency, and sponsor viewpoints on the impact of this long-awaited submission standard.
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)
Mark A. Gray
Senior Project Manager, DSB, CBER, FDA, United States
FDA Perspective on RPS/eCTD 4
Olga Alfieri, MBA, MSC, RAC
Senior Director, Global Submission Management & Operations, Eisai Co., Ltd., United States
Industry Perspective on RPS/eCTD 4
Joel Finkle
Industry Expert, Retired, United States
Vendor Perspective on RPS/eCTD 4
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