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This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document. As standards continue to evolve, this introductory course is designed to provide life sciences professionals with a foundation in the fundamental concepts of the electronic Common Technical Document (eCTD) in order to facilitate awareness and understanding of the quickly evolving regulatory landscape. Areas Covered in the Seminar: - ICH Overview and Origins of CTD.
- CTD and eCTD.
- CTD/eCTD Structure.
- Module Structure.
- Authoring, Lifecycle Management, and Submission Type Considerations.
- Basic Differences Between Paper and Electronic.
- eCTD: Technical Introduction.
- Preparing eSubmission ready documents to go in the eCTD.
- File Naming.
- Document Properties.
- Open Settings.
- PDF Version.
- Bookmarks and Hyperlinks.
- Setting up the XML backbone to deliver the eCTD.
- What is the XML backbone?
- What file formats go in the eCTD?
- Where do files go?
- Introduction to Metadata.
- Study Tagging Files vs Node Extensions.
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