Regulatory Education for Industry (REdI) Annual Conference 2023 – Day 1 – Session 3

FDA speakers outline the evolution and modernization of Electronic Submissions Gateway (ESG) along with plans for the next generation, provide an FDA eCTD v4.0 Implementation Update, and discuss metrics, best practices, and most common validation errors.

Timestamps

01:29 – ESG (Electronic Submissions Gateway)…The Road to Modernization

32:03 – eCTD v4.0 Implementation Update

53:36 – Electronic Submission Practicalities and Application Tips

01:14:04 – Q&A Discussion Panel

Speakers:

Jessica Bernhardt, MS
AdminApps Program Manager, ESG Program Manager
Office of Information Management & Technology (OIMT)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC)

Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER

Heather Crandall
Operations Research Analyst
DDMSS | OBI | OSP | CDER

Panelists:

Same as above

Learn more at: https://www.fda.gov/drugs/news-events...

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