Training Agenda

Introductory Session (1.1): 8:30 – 10 am	Introduction to Electronic Submissions and eCTD Introduction to Technical Foundations and Publishing Basics: PDF Documents SAS Datasets Hands on Activity re: Checklists Worldwide status of the eCTD Demonstrations of application types: eNDA/Hybrid vs eCTD
Morning Session (1.2): 10:30 - Noon	Preparing for eCTD: guidance and definitions In depth review of publishing standards: Process Impacts of eCTD Introduction to CRFs Introduction to CRTs Introduction to CSRs and non-clinical Cross referencing strategy utilizing CMC
Lunch
Afternoon Session (1.3): 1-2:30 pm	In depth review of eCTD Requirements eCTD Metadata Attributes eCTD Lifecycle Management – use of operators eCTD Regulatory Operations organization impacts eCTD Metadata ‘mapping’ activity
Wrap-up Session (1.3): 3-4 pm	Brief overview of other electronic standards activities (ie. SPL, CDISC) Questions and Answers Assessment of Training

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