Tue, 30 May|
ONLINE: GOOGLE MEETS
ONLINE TRAINING: COMPILATION OF THE SAHPRA CTD- Module 1/2/3/4/5 (Over 10 DAYS)
UPSKILL FOR THE NEW YEAR 2023! 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 & COMPLEMENTARY
Time & Location
30 May 2023, 08:00 – 28 Jun 2023, 16:30
ONLINE: GOOGLE MEETS
About The Event
This interactive EIGHT-DAY training course over the month of MAY 2023 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 10 day training course (Compulsory to attend ALL 10 days)
- Tuesday 30 May & Wednesday 31 May 2023
- Tuesday 06 June & Wednesday 06 June 2023
- Tuesday 13 June & Wednesday 14 June 2023
- Tuesday 20 June & Wednesday 21 June 2023
- Tuesday 27 June & Wednesday 28 June 2023
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.
NB! The price excluding VAT = R25 995,00 for the mornings. This Ticket includes access to online training course and any shared training materialR 25 995,00Tax: +R 3 899,25 VAT