This training program (2 FULL days) will cover an in-depth discussion of Module 3 technical and scientific requirements as detailed in EMA & SAHPRA guidelines.

This training course introduces you to the Common Technical Document (CTD), as designed by the ICH (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). You will become more familiar with the  TECHNICAL & SCIENTIFIC REQUIREMENTS FOR: 

• CTD MODULE 3 (3.2.S/3.2.P/3.2.A/3.2R)
• &
• LINK TO ALL FORMS & MODULE 1

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.

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.