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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Phase Appropriate Expectations for Analytical Methods and Process Validation for Expedited Programs: A Regulatory Perspective
Speaker Presentation Powdrill Megan, Health Canada, 2020
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Merck's Approaches and Challenges for Implementation of Phase-Appropriate GMP Continuum
Speaker Presentation Mabe Todd, Akouos Inc., 2020
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Validation and Implementation of an Automated Colony Counter for Product Testing in Biopharmaceutical Manufacturing
Speaker Presentation Deutschmann Sven, Roche Siagnostics GmbH, 2020
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Expedited Programs: Phase Appropriate Regulatory Expectations for Microbial Control and Sterility Assurance
Speaker Presentation Hughes Patricia, CDER, FDA, 2020
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Taking Stability Off the Critical Path of Product Development
Speaker Presentation Lennard Andrew, Amgen Limited, 2020
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Specific Regulatory Strategies for Process Validation for Biologics
Speaker Presentation Wilkinson Diane, AstraZeneca, 2020
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Commercial Process Control Strategy Considerations for Cell Therapy Products
Speaker Presentation Rajendran Saravanamoorthy, Bristol-Myers Squibb Company, 2020
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Regulatory Approaches for Accelerated Development in Europe
Speaker Presentation Welin Mats, Swedish Medical Products Agency, 2020
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Pandemic Preparedness: Regulatory Agility in the Era of COVID-19
Speaker Presentation Fernandes Jason, Health Canada, 2020
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Vaccine Development and Licensure Pathways: An Emerging Infectious Disease Vaccine Example
Speaker Presentation Levis Robin, CBER, FDA, 2020
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Expedited Programs and Challenges to Biologics Manufacturing
Speaker Presentation Kirshner Susan, CDER, FDA, 2020