ComplianceOnline, the governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, announced a seminar on Biosimilars Analytical Characterization and Comparability Studies. The two day long seminar by respected regulatory affairs expert Dr. Nanda Subbarao will be held on January 24 and 25, 2013 in San Diego, CA.
A comprehensive analytical strategy which meets current regulatory expectations will reduce the cost of biosimilar development program. This seminar will give guidance to analytical package required for a biosimilar product.
Seminar instructor Dr. Nanda Subbarao has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase.
She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. During the one and half a day seminar Dr Subbarao will focus on current status of global biosimilar guidance and analytical package required for a biosimilar product. She will also focus on analytical comparability studies currently required for comparison of the reference product with the biosimilar. Dr. Subbarao will also explain the analytical methods and specifications required for both comparability studies and lot release and stability studies.
For more information or to register for the seminar, please click here.