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.

Steps to register:

1) Choose the quantity of seats you want (delegates can only book more than 1 seat if from the same company), & then click the “checkout” button.

2) Enter personal information & click the “confirm & proceed” button.

3) You will then be directed to a page reflecting the Twinz Foundation banking details (note that payments can only be processed via EFT & once you receive an invoice).

4) Click the “buy now” button to finalise registration (note payment is not required at this stage).

5) Once you have completed steps 1 to 4, you will receive, via email, a booking confirmation ticket and shortly thereafter an invoice.

6) Once you make payment, you will receive a valid ticket for attendance.

7) If you have registered for the training and payment is not received 48 hrs prior to the start of the training, you will be liable for full payment of the course even if you decide not to attend unless you have made prior arrangements with the provider.