REdI2024 D2S04 1

This presentation explained what the ESG NextGen system encompasses and provided background information on the vision behind the Electronic Submission Gateway Next Generation platform. The session highlighted industry engagement and collaboration efforts in developing the system. A demonstration of ESG NextGen functionality was included to showcase the platform's capabilities and improvements over previous submission gateway systems. Timestamps 00:43 – What is ESG NextGen? 03:53 – Background & Vision 14:02 – Industry Engagement & Collaboration 22:15 – Demo 28:36 – Key Take Aways Speaker: Jessica Bernhardt, MS ESG Program Manager Division of Application Services (DAS) Enterprise Application Branch (EAB) Office of Digital Transformation (ODT) Office of Information Management and Technology (OIMT) | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367