Transitioning from Paper to Electronic Format:Lessons Learned from Regulatory eCTD Submissions

Monday, September 22, 2014 — Poster Session I
12:00 p.m. – 2:00 p.m.	FAES Academic Center	NIAID	RSCHSUPP-10

Authors

• L.H. Giambarresi
• S.C. Garrand
• M.A. Chakrabarti
• V.S. Eccard
• A.L. Gonzalez
• M.L. Baracz
• L.M. Lacuesta
• M.J. Buehn

Abstract

The eCTD process is complex and ever evolving. Since the RCHSPP’s first eCTD submission in April 2011, many processes have been refined and lessons learned. Listed here, in no specific order, are the ten most important lessons we have learned when implementing eCTD submission processes. Awareness of these lessons has allowed us to increase efficiency and accuracy in our FDA submissions.

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