Research and Markets (http://www.researchandmarkets.com/research/jg3bpg/biotechbiosimilar)
has announced the addition of the "Biotech/Biosimilar
Products: Current and Emerging Analytical CMC Expectations: 2-Day
In-Person Seminar" conference to their offering.
In the development and commercialization of biopharmaceutical products,
historically most of the R&D and GMP attention has been focused on the
manufacturing process and production facility. However, there has always
been a vital role for the other half of the equation: analytical testing
and laboratory operations.
The global emergence of biosimilar products - where significant
attention is given to analytical characterization and comparability -
has turned a brighter spotlight on the analytics. It is expected that
rationale for the design and execution of analytical studies, the
selection of and validation of appropriate method technologies, the
assessment of drug substance and drug product stability, and the
establishment of meaningful, supportable specifications will be
justified in regulatory dssiers.
This two-day interactive course on CMC requirements for
biopharmaceutical products will focus on the types of analytical CMC
studies that are critical to the successful review and approval of
product IND/IMPD and BLA/MAA filings. It will also discuss the vital
role of laboratory quality systems in assuring the reliability and
integrity of the data generated to demonstrate product comparability,
quality and stability.
Upon completing this course on analytical CMC regulations,
Following personnel will benefit from the course:
For more information visit http://www.researchandmarkets.com/research/jg3bpg/biotechbiosimilar
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