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CMC Strategies for Expedited Program Development — Regulatory Perspectives
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CMC Summary Paper: CMC Strategy Forum North America Fall 2020 -
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
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Strategies to Establish Release Specifications for Peptide Maps
CMC Summary Paper: CMC Strategy Forum North America Fall 2002
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Mycoplasma In-Process and Lot Release Test: To PCR Or Not To PCR
CMC Summary Paper: CMC Strategy Forum North America Fall 2003
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