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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)
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 Pharmaceuticals, 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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