This 90-minute webinar will cover the global Biosimilar guidances and provide an overview of analytical studies for a Biosimilar CMC package.
Why Should You Attend:
Analytical characterization and comparability studies will determine the amount of Clinical and non-clinical studies required for registration of a Biosimilar product. Hence, Analytical Strategy is a critical element of Biosimilar product development plan. A comprehensive analytical package can minimize the amount of clinical studies and control costs of a Biosimilar development program.
This 90-minute session will review the global Biosimilar guidances and provide an overview of analytical studies for a Biosimilar CMC package.
Areas Covered in the Seminar:
- Overview of the Global Biosimilar guidances.
- Choice of the Reference Product.
- Analytical methods required for characterization of a Biosimilar product.
- Characterization of the Reference Product.
- Comparability of the Biosimilar product to the Reference Product.
Added by complianceonlinecom on July 24, 2012