Resources
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Mechanisms of Surfactant Degradation: Focus on Enzymatic Hydrolysis
Speaker Presentation Huang Lihua, Eli Lilly and Company, 2020
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A Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
Speaker Presentation Hubert Mario, Bristol-Myers Squibb Company, 2020
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Visible Particles from Polysorbate Degradation
Speaker Presentation Nikels Felix, Boehringer Ingelheim Pharma GmbH & Co. KG, 2020
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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
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Update of Q12 Implementation in Japan
Speaker Presentation Yagi Satomi, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Introduction of Post-approval Change Management Protocol (PACMP) Mock-up in Japan Preparation
Speaker Presentation Funato Keiko, GlaxoSmithKline K. K., 2020
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Case Study: Industry Experience from PACMP Pilot Program in Japan
Speaker Presentation Kubodera Yoshinori, Chugai Pharmaceutical Co. Ltd., 2020
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ICH Q12 Update and Reflections on the USFDA Established Conditions Pilot Program
Speaker Presentation Welch Joel, CDER, FDA, 2020
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Regulatory Approaches to CMC Development During COVID-19: Challenges and Opportunities
Speaker Presentation Shapiro Marjorie, CDER, FDA, 2020
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Regulatory Challenges: Expediting CMC Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2020