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REGULATORY REQUIREMENTS FOR BIOLOGICAL/BIOSIMILAR PRODUCTS (2 Days)
Wed, 17 Sept
|Online Google Meets
Concepts & regulatory documentation requirements Plus SAHPRA/EMA GUIDELINES
Time & Location
17 Sept 2025, 08:00 – 18 Sept 2025, 16:00
Online Google Meets
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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