Mon, 07 Jun | ONLINE: GOOGLE MEETS

ONLINE TRAINING: COMPILATION OF THE SAHPRA CTD- Module 1/2/3/4/5 (Over 8 DAYS)

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
ONLINE TRAINING: COMPILATION OF THE SAHPRA CTD- Module 1/2/3/4/5 (Over 8 DAYS)

Time & Location

07 Jun, 08:30 SAST – 30 Jun, 16:00 SAST
ONLINE: GOOGLE MEETS

About The Event

This interactive EIGHT-DAY training course over the month of JUNE 2021 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 07 & Tuesday 08 June 2021
  • Monday 14 & Tuesday 15 June 2021
  • Monday 21 & Tuesday 22 June 2021
  • Monday 28 & Tuesday 29 June 2021

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

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.

Tickets
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  • NORMAL TICKET
    ZAR 25,995
    +ZAR 3,899.25 VAT
    ZAR 25,995
    +ZAR 3,899.25 VAT
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