Mon, 06 Jun|
ONLINE: GOOGLE MEETS
ONLINE TRAINING: COMPILATION OF THE SAHPRA CTD- Module 1/2/3/4/5 (Over 8 DAYS) (1)
UPSKILL FOR THE NEW YEAR 2022! Do you know how to compile the ZACTD? This short course will introduce you to all relevant legislation & SAHPRA/EMA/ICH guidelines when compiling a ZACTD (NCE/GENERIC): ALLOPATHIC MEDICINES
Time & Location
06 Jun, 08:00 – 28 Jun, 16:00
ONLINE: GOOGLE MEETS
About The Event
This interactive EIGHT-DAY training course over the month of FEBRUARY 2022 will provide you with a clear and comprehensive understanding of SAHPRA regulatory requirements for the CTD application and discuss requirements for compilation. Note that e-submission format will be covered ONLY.
Dates for the full 8 day training course (Compulsory to attend ALL 8 days)
- Monday 31 January & Tuesday 01 February 2022
- Monday 07 February & Tuesday 08 February 2022
- Monday 14 February & Tuesday 15 February 2022
- Monday 21 February & Tuesday 22 February 2022
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.
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.
+ZAR 3,899.25 VAT
NB! The price excluding VAT = R25 995,00 for the mornings. This Ticket includes access to online training course and any shared training material
+ZAR 3,899.25 VAT0