| Introductory Session (1.1): 8:30 10 am |
Introduction to Electronic Submissions and eCTD
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| Morning Session (1.2): 10:30 - Noon |
Preparing for eCTD: guidance and definitions In depth review of publishing standards: Process Impacts of eCTD
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| Lunch | |
| Afternoon Session (1.3): 1-2:30 pm |
In depth review of eCTD Requirements
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| Wrap-up Session (1.3): 3-4 pm |
Brief overview of other electronic standards activities (ie. SPL, CDISC)
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