Resources
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In-Use Studies Microbial Challenge Studies: Cross-Industry Efforts to Harmonize Strategies in Collaboration with Health Authorities
Speaker Presentation Kirwan J. Paul Amgen Inc. 2024 -
In-use Testing of Cell and Gene Therapies
Speaker Presentation Foster Abbygail Genentech, a Member of the Roche Group, and Grossen Phillip F. Hoffman-La Roche Ltd. 2024
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How to Design and Perform In-Use Stability and Compatibility Studies?
Speaker Presentation Blümel Markus Novartis Pharma AG 2024
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CMC Strategy Forum North America 2024 Scientific Program
Scientific Program: CMC Strategy Forum North America 2024
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CMC Strategy Forum North America 2024 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2024
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Stability Predictions for mAbs Using Arrhenius-Based Kinetics
Speaker Presentation Zidar Mitja Novartis 2023
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CMC Strategy Forum Japan 2023 - Welcome and Introductory Comments
Speaker Presentation Suzuki Hiroshi PMDA 2023
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Current Situation and Issue on Stability Prediction of Biopharmaceuticals from Regulatory Perspective
Speaker Presentation Shibata Hiroko NIHS 2023
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Basic Approach for Comparability Assessment of Cell Therapy Products Subject to Changes in Their Manufacturing Process
Speaker Presentation Sato Yoji NIHS 2023
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Modeling for Product-specific Stability: A Regulatory Perspective
Speaker Presentation Russell Paula Health Canada 2023
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Quality Assessment of Antibody-Drug Conjugate
Speaker Presentation Nakano Ayuki PMDA 2023
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ICMRA PQKMS Pilots – the Roche Experience
Speaker Presentation Markus Goese Roche 2023
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Center for Biologics Evaluation and Research (CBER) Updates
Speaker Presentation Markovic Ingrid CBER, FDA 2023
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Change Management and Comparability for Cellular & Gene Therapy Products
Speaker Presentation Markovic Ingrid CBER, FDA 2023
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Current ATMP Regulation in China
Speaker Presentation Lu Jiaqi Center for Drug Evaluation (CDE) 2023
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Regulatory Updates and a Perspective on Biopharmaceuticals in Japan
Speaker Presentation Kishioka Yasuhiro PMDA 2023
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Concerns and Expectations Regarding Stability Assessment with Modeling-Type Extrapolation in Biological Products, as Pertains to Revisions of ICH Q1/Q5C Guidelines
Speaker Presentation Kameda Takashi PMDA 2023
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Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients
Speaker Presentation Hamel Hugo Health Canada 2023
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Regulatory Update from Europe
Speaker Presentation Dooley Brian European Medicines Agency (EMA) 2023
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Navigating Global Regulations for Antibody Drug Conjugates (ADCs) - A CMC Perspective
Speaker Presentation Chauhan Vandana Gilead Sciences, Inc. 2023