Biosimilars: CMC Development and Regulatory Strategies
Module 1 is Free to Attend – Register Below
Learn more about the course (dates, price, skills gained, and when module 1 is) by visiting the course page.
Module 1 Overview | Understanding CMC and Regulatory Foundations for Biosimilars
Live and Recorded | 60 Minutes
Understanding CMC and Regulatory Foundations for Biosimilars
- Understand the fundamental differences between biologics, biosimilars, and generics.
- Explain why “the process is the product” in biosimilar development.
- Identify key CMC and analytical comparability challenges.
- Recognise the global regulatory framework for biosimilars (EMA, FDA, WHO).
- Appreciate the importance of Module 3 (Quality) in biosimilar submissions.
Register for the free Module 1 by completing the form below. You will be sent joining instructions and more information about the course (agenda, trainers, pricing etc).