About
Characterization and Comparability Testing of Biosimilars (Biosimilar Analytics)
| Date: | 28-Aug-12 to 28-Aug-12 |
| Location: | Online Event / United States |
| Category: | Agriculture, Farming & Forestry Conferences & Trade Fairs |
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.
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.
Visitors
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.
Event Details:
Date: August 28, 2012
Time: 10:00 AM - 11:30 AM PDT
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
- 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.
Event Details:
Date: August 28, 2012
Time: 10:00 AM - 11:30 AM PDT
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
Exhibitors
Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases.
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