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.
Who will Benefit:

- Stability department personnel
- R&D Laboratory personnel
- R&D Laboratory Supervisors and Management
- QC Laboratory personnel and management
- Protein Formulation Group personnel and Management.
- Regulatory Affairs personnel.
- Regulatory Affairs Management.
- QC Laboratory personnel and management.