This interactive EIGHT to TEN-DAY training course over  a few weeks (5 weeks) will provide you with a clear and comprehensive understanding of SAHPRA regulatory requirements for the CTD application and discuss requirements for compilation. 

Dates for the full 8 day training course (Compulsory to attend ALL 8-10 days)

• Thursday 23 May & Friday 24 May (Friday end at 13:00)
• Thursday 30 May & Friday 31 May (Friday end at 13:00)
• Monday 03 June & Thursday 06 June 
• Tuesday 11 June & Thursday 13 June 
• Monday 01 July & Tuesday 02 July

Skills you will gain include:

• Effective compilation of the Common Technical Document (CTD) and critical review of documentation
• Compiling and submitting Module 1; 2; 3; 4; 5 (CTD) of your registration dossier
•        *Module 1 – Administrative Information
•        *Module 2 - CTD Summaries
•        *Module 3 – Quality
•        *Module 4 - Non-clinical study reports
•        *Module 5 - Clinical Study Reports
• Identifying the extent of content expected by SAHPRA 
• Achieving the quickest turnaround of your submission
• eSubmisison formatting requirements

You will be given access to guidelines that specify in detail the structure of Module 3 of the CTD and the relationship between Modules and the documents that make up a dossier. Detailed review of ICH/EMA guidelines that impact on Module 3.

Best practices and recommendations 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.