1 day course

Compilation of the professional information and patient information leaflet:

- South African Legislation including Regulations 

- SAHPRA guidelines, covering PI & PIL format

- Compilation of Innovator and Generic PI/PILs utilising different reference documents e.g. SmPC; ZA innovator PI

- Overview of Clinical variations 

- General information

- USRNS

- Safety & Medicines Safety Alerts

- Relevance of CCDS & PSURs/ PBRER

- Referencing System

 Why you should attend?

• This course is ideally aimed at Regulatory Affairs personnel whom require the essential "know-how" on creating/updating a PI/PIL.

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.