REdI 2024 | D2S03-1 - ECTD v4.0 Implementation Update скачать в хорошем качестве

REdI 2024 | D2S03-1 - ECTD v4.0 Implementation Update

This presentation provided an understanding of fundamental eCTD v4.0 concepts and discussed FDA's implementation strategy for the new version. The session outlined key changes and improvements in eCTD v4.0 compared to previous versions. Practical guidance for preparing for eCTD v4.0 implementation was shared to help stakeholders successfully transition to the updated electronic Common Technical Document format. Timestamps 00:44 – eCTD v4.0 Goals 01:15 – eCTD v4.0 Concepts 10:10 – FDA eCTD v4.0 Implementation Strategy 15:39 – Prepare for eCTD v4.0 17:36 – Summary Speaker: Jonathan Resnick Project Management Officer Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI) Office of Strategic Programs (OSP) Center for Drug Evaluation and Research (CDER) | 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