Papers and Presentations
How to Search for Resources
You can search for a variety of content on the CASSS website. CASSS makes available any content with author approval. Narrow your search by using the various filters shown below, such as Resource Type, Event Type, and Year. Refine your search as needed.
Transforming Global Regulatory CMC Practices
"Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation" features a panel of esteemed regulatory experts, including representatives from ANVISA, US FDA, EMA, PMDA, and WHO, who share their invaluable insights on global harmonization. View the Plenary Session
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Challenges Facing Biopharmaceutical Development in the Next Decade
CMC Summary Paper: CMC Strategy Forum Europe 2010
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Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says
CMC Summary Paper: CMC Strategy Forum Europe 2010 - 2
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The Role of Higher Order Structure in Defining the Quality of Biopharmaceutical Products
CMC Summary Paper: CMC Strategy Forum North America Winter 2010 - 2
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Analytical Characterization and Regulatory Considerations for Antibody-Drug Conjugates: Uniting Small Molecule and Biologic Drug Perspectives
CMC Summary Paper: CMC Strategy Forum North America Winter 2010
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QbD for Biologics: Learning's from the Product Development and Realization Case Study (A-Mab) and the FDA OBP Pilot Program
CMC Summary Paper: CMC Strategy Forum North America Summer 2010