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Wed, 08 May

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Online Google Meets

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

UPSKILL FOR THE NEW YEAR 2024! 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

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

Time & Location

08 May 2024, 08:15 – 30 May 2024, 16:00

Online Google Meets

About The Event

This interactive EIGHT-DAY training course over the month of MAY 2024 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 8 day training course (Compulsory to attend ALL 8 days)

  • Wednesday 08 May & Thursday 09 May 
  • Wednesday 15 May & Thursday 16 May 
  • Wednesday 22 May & Thursday 23 May 
  • Wednesday 29 May & Thursday 30 May 

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.

Tickets

  • Normal Ticket

    NB! The price excluding VAT = R25 995,00 for the mornings. This Ticket includes access to online training course and any shared training material

    R 25 995,00
    Tax: +R 3 899,25 VAT

Total

R 0,00

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