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REGULATORY REQUIREMENTS FOR BIOLOGICAL/BIOSIMILAR PRODUCTS (2 Days)

Date and time is TBD

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Concepts & regulatory documentation requirements Plus SAHPRA/EMA GUIDELINES

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REGULATORY REQUIREMENTS FOR BIOLOGICAL/BIOSIMILAR PRODUCTS (2 Days)
REGULATORY REQUIREMENTS FOR BIOLOGICAL/BIOSIMILAR PRODUCTS (2 Days)

Time & Location

Date and time is TBD

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About The Event

This training program (Over 2 Full DAYS) will cover an in-depth discussion of Biological & Biosimilar technical and scientific requirements as detailed in EMA & SAHPRA guidelines.

This training course introduces you to relevant concepts within the Biological space.

You will become more familiar with the  TECHNICAL & SCIENTIFIC REQUIREMENTS FOR BIOLOGICALS: 

  • CTD MODULE 1
  • CTD MODULE 3 
  • MODULE 4 & 5 

Best practices and recommendations will be shared.

Steps to register:

1) Choose the number of tickets you want & 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.

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DISCLAIMER: Do note that the courses where we state a date TO BE DETERMINED (TBD), will be planned for, only if you register and we  subsequently have a minimum of 5 people who have registered. NO PAYMENT FOR THE COURSE IS REQUIRED UPON REGISTRATION. We will liaise with you regarding the date to host a particular course in order to accommodate as best possible for all prospective attendees.

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