SAHPRA eSUBMISSION ZACTD Formatting
Tue, 17 May
|Online Training
Time & Location
17 May 2022, 08:00 – 13:00
Online Training
About The Event
This interactive training course provides a clear and comprehensive understanding of SAHPRA regulatory requirements for the eSUBMISSION & eCTD ZACTD FORMATTING as well as practical processing techniques.
Skills that will be gained include:
- Effective formatting of an eSubmission & eCTD Common Technical Document (CTD)
- Familiarity with SAHPRA GUIDELINES:
1. eSubmission guideline
2. eCTD guideline
3. ICH guidelines
- e-Folder structure
- Naming of e-folders and e-documents
- Hyperlinking to Table of Contents
- Other electronic requirements such as OCR scanning etc.
- Hyperlinking of the SAHPRA validation template
- Hyperlinking Module 2.3 to Module 3
- Hyperlinking of PI/PIL (different to general hyperlinking)
- Bookmarking (and specific settings for the bookmarks and electronic files)
- Removing metadata
- File/document optimization
- Working documents folder – file naming
- eSubmisison & eCTD formatting requirements
Access will be given to the specific SAHPRA guidelines & best practices and recommendations gained through our experiences will be shared.