Papers and Presentations
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ICH Q1s/5C Revision – Opportunities in Science and Risk-Based Testing Approaches for Biologics
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/cmc-japan/2023/cmcj2023_120x120_landing.jpg?sfvrsn=f8332483_12)
Speaker Presentation: CMC Strategy Forum Japan 2025Zimmermann Boris, Genentech, a Member of the Roche … -
Workshop III Introduction
Speaker Presentation: CMC Strategy Forum Japan 2025Workshop III Introduction
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rAAV as a Heterogeneous Particle Ensemble: Current Understanding of Its Quality Attributes
Speaker Presentation: CMC Strategy Forum Japan 2025Uchiyama Susumu, Osaka University, 2025
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Industry Perspective on Implementation of AI and Machine Learning in Manufacturing - Emerging Regulatory Landscape
Speaker Presentation: CMC Strategy Forum Japan 2025Thurau Gert, F. Hoffmann-La Roche Ltd., 2025
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ICH Q12 Implementation in Japan, and Current Situation of ICH M4Q(R2)
Speaker Presentation: CMC Strategy Forum Japan 2025Tanaka Keisuke, PMDA, 2025
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Regulatory Perspectives on Model-Informed Decision-Making to Support Biologic Drug Development and Market Applications
Speaker Presentation: CMC Strategy Forum Japan 2025Siggers Jayda, Health Canada, 2025
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Challenges and Approaches Related to Extrapolation and Shelf Life/re-Test Period Setting in Biological Products
Speaker Presentation: CMC Strategy Forum Japan 2025Shibata Hiroko, National Institute of Health …
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Challenges of Manufacturing of AAV for Gene Therapy Products, Focusing on Upstream and Downstream Processes
Speaker Presentation: CMC Strategy Forum Japan 2025Sakurai Takashi, Astellas Pharma Inc., 2025
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PQS Effectiveness, ICH Q9(R1) & Using the CMC Regulatory Tools of ICH Q12 – a European Regulator’s Perspective
Speaker Presentation: CMC Strategy Forum Japan 2025O'Donnell Kevin, Health Products Regulatory Authority …
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Regulatory Update From European Medicines Agency
Speaker Presentation: CMC Strategy Forum Japan 2025Mihokovic Nino, European Medicines Agency (EMA), …
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Quality Considerations in the Development of AAV Vector Products
Speaker Presentation: CMC Strategy Forum Japan 2025Maeda Kenichiro, PMDA, 2025
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“Tradition Is a Guide Not a Jailer”: Standard Versus Alternative Approaches in the ICH Q1 Revision
Speaker Presentation: CMC Strategy Forum Japan 2025Lennard Andrew, Amgen Inc., 2025
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Regulatory Updates and a Perspective on Biologics in Japan
Speaker Presentation: CMC Strategy Forum Japan 2025Kuribayashi Ryosuke, PMDA, 2025
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Overview of the ICH-Q1 Guideline Revision Draft and Prospects for Stability Assessment of Biological Products from the Regulatory Perspective
Speaker Presentation: CMC Strategy Forum Japan 2025Kameda Takashi, PMDA, 2025
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EMA Quality Innovation Group (QIG): Two Years Experience in Regulatory Support of Innovation in Pharmaceutical Manufacturing
Speaker Presentation: CMC Strategy Forum Japan 2025Hoefnagel Marcel, Medicines Evaluation Board …
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Continuous Manufacturing and Portable On-Demand (POD) for Biologics: Development Challenges and Regulatory Considerations
Speaker Presentation: CMC Strategy Forum Japan 2025Furuki Kenichiro, Merck Sharp & Dohme, 2025
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Characterising Viral Vectors for Gene Therapy Delivery Using Mass Spectrometry on Different Levels
Speaker Presentation: CMC Strategy Forum Japan 2025Bones Jonathan, NIBRT, 2025
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In-line Raman Spectroscopy for Process Characterization
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/discussion-groups/dg2024_landing_120x120.jpg?sfvrsn=4e17be5c_3)
Speaker Presentation: Netherlands Area Biotech Discussion Group 2025Klijn Marieke, Delft University of … -
Regulatory Expectations for Real-Time PAT and Continuous Manufacturing
Speaker Presentation: Netherlands Area Biotech Discussion Group 2025Hoefnagel Marcel, Medicines Evaluation …
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A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
Speaker Presentation: VEDG 2025Van Tricht Ewoud, Sanger van de Griend Cari, Kantisto BV, 2025