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.