ComplianceOnline, Online Event
2012-08-28
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.
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.
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Invited Speakers:
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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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