Resources
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CMC Strategy Forum North America 2026 Scientific Program
Scientific Program: CMC Strategy Forum North America 2026
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CMC Strategy Forum North America 2026 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2026
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WCBP 2026 Summary Infographic
Summary Infographic: WCBP 2026
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ICH Q1s/5C Revision – Opportunities in Science and Risk-Based Testing Approaches for Biologics
Speaker Presentation: CMC Strategy Forum Japan 2025
Zimmermann Boris, Genentech, a Member of the Roche Group, 2025 -
Workshop III Introduction
Speaker Presentation: CMC Strategy Forum Japan 2025
Workshop III Introduction -
rAAV as a Heterogeneous Particle Ensemble: Current Understanding of Its Quality Attributes
Speaker Presentation: CMC Strategy Forum Japan 2025
Uchiyama Susumu, Osaka University, 2025 -
Industry Perspective on Implementation of AI and Machine Learning in Manufacturing - Emerging Regulatory Landscape
Speaker Presentation: CMC Strategy Forum Japan 2025
Thurau Gert, F. Hoffmann-La Roche Ltd., 2025 -
ICH Q12 Implementation in Japan, and Current Situation of ICH M4Q(R2)
Speaker Presentation: CMC Strategy Forum Japan 2025
Tanaka Keisuke, PMDA, 2025 -
Regulatory Perspectives on Model-Informed Decision-Making to Support Biologic Drug Development and Market Applications
Speaker Presentation: CMC Strategy Forum Japan 2025
Siggers Jayda, Health Canada, 2025 -
Challenges and Approaches Related to Extrapolation and Shelf Life/re-Test Period Setting in Biological Products
Speaker Presentation: CMC Strategy Forum Japan 2025
Shibata Hiroko, National Institute of Health Sciences, 2025 -
Challenges of Manufacturing of AAV for Gene Therapy Products, Focusing on Upstream and Downstream Processes
Speaker Presentation: CMC Strategy Forum Japan 2025
Sakurai Takashi, Astellas Pharma Inc., 2025 -
PQS Effectiveness, ICH Q9(R1) & Using the CMC Regulatory Tools of ICH Q12 – a European Regulator’s Perspective
Speaker Presentation: CMC Strategy Forum Japan 2025
O'Donnell Kevin, Health Products Regulatory Authority (HPRA) Ireland, 2025 -
Regulatory Update From European Medicines Agency
Speaker Presentation: CMC Strategy Forum Japan 2025
Mihokovic Nino, European Medicines Agency (EMA), 2025 -
Quality Considerations in the Development of AAV Vector Products
Speaker Presentation: CMC Strategy Forum Japan 2025
Maeda Kenichiro, PMDA, 2025 -
“Tradition Is a Guide Not a Jailer”: Standard Versus Alternative Approaches in the ICH Q1 Revision
Speaker Presentation: CMC Strategy Forum Japan 2025
Lennard Andrew, Amgen Inc., 2025 -
Regulatory Updates and a Perspective on Biologics in Japan
Speaker Presentation: CMC Strategy Forum Japan 2025
Kuribayashi Ryosuke, PMDA, 2025 -
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 2025
Kameda Takashi, PMDA, 2025 -
EMA Quality Innovation Group (QIG): Two Years Experience in Regulatory Support of Innovation in Pharmaceutical Manufacturing
Speaker Presentation: CMC Strategy Forum Japan 2025
Hoefnagel Marcel, Medicines Evaluation Board (MEB), 2025 -
Continuous Manufacturing and Portable On-Demand (POD) for Biologics: Development Challenges and Regulatory Considerations
Speaker Presentation: CMC Strategy Forum Japan 2025
Furuki Kenichiro, Merck Sharp & Dohme, 2025 -
Characterising Viral Vectors for Gene Therapy Delivery Using Mass Spectrometry on Different Levels
Speaker Presentation: CMC Strategy Forum Japan 2025
Bones Jonathan, NIBRT, 2025