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REGULATORY REQUIREMENTS FOR BIOLOGICAL/BIOSIMILAR PRODUCTS (2 Days)

Tue, 09 Jun

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Concepts & regulatory documentation requirements Plus SAHPRA/EMA GUIDELINES

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

Time & Location

09 Jun 2026, 08:00 – 11 Jun 2026, 16:00

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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 


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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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