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Regulated Product Submissions and eCTD 4: The Path to Progress

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
214

Room Number:
30AB

Level:
Intermediate

Type:
Session

Title:
Regulated Product Submissions and eCTD 4: The Path to Progress

Chair(s):
Joel Finkle
Senior Strategist, Regulatory Informatics
CSC Life Sciences, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
FDA Perspective on RPS/eCTD 4
Mark A. Gray
Director, Division of Data Management Services and Solutions, OBI, CDER
FDA, United States

Industry Perspective on RPS/eCTD 4
Olga Alfieri, MBA, RAC
Associate Director, Global Submissions Management (US)
Eisai Co., Inc., United States

Vendor Perspective on RPS/eCTD 4
Joel Finkle
Senior Strategist, Regulatory Informatics
CSC Life Sciences, United States