Resources
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WCBP 2025 Summary Infographic
Summary Infographic: WCBP 2025
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WCBP 2025 Scientific Program
Scientific Program: WCBP 2025
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CMC Strategy Forum North America 2025 Scientific Program
Scientific Program: CMC Strategy Forum North America 2025
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CMC Strategy Forum North America 2025 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2025
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Establishment of Specifications for Monoclonal Antibodies
Speaker Presentation: CMC Strategy Forum Japan 2024
Yu Chuanfei, NIFDC, 2024 -
ICH Q6 Revision Towards Globally Harmonized Specifications
Speaker Presentation: CMC Strategy Forum Japan 2024
Yamaguchi Takahiro, JPMA, 2024 -
Challenges in the Clinical Implementation of piggyBac Transposon Mediated CAR-T Cell Therapy
Speaker Presentation: CMC Strategy Forum Japan 2024
Yagyu Shigeki, A-SEEDS, 2024 -
Role of ICH Q2/Q14 and ICH Q6 on Establishment of Control Strategy
Speaker Presentation: CMC Strategy Forum Japan 2024
Shibata Hiroko, PMDA, 2024 -
Regulatory Updates and a Perspective on Biopharmaceuticals in Japan
Speaker Presentation: CMC Strategy Forum Japan 2024
Sakurai Akira, PMDA, 2024 -
Expectations for ICH M4Q(R2) from an Industry Point of View
Speaker Presentation: CMC Strategy Forum Japan 2024
Ohtsuka Hiroshi, Bayer Yakuhin, Ltd., 2024 -
Quality Control of the Raw Materials for Cell and Gene Therapy Products
Speaker Presentation: CMC Strategy Forum Japan 2024
Nishikawa Atsushi, PMDA, 2024 -
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session IV] -
ICH Efforts Towards Developing a Unified ICH Q6 Guideline and Modernizing Global Standards for Specifications Setting
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session III] -
Update on the Initiatives at the Center for Biologics Evaluation and Research (CBER), U.S. FDA
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session I] -
Update on ICH M4Q(R2)
Speaker Presentation: CMC Strategy Forum Japan 2024
Kishioka Yasuhiro, PMDA, 2024 -
ICH Cell & Gene Therapy Discussion Group: Progress Toward Delivering a Strategic Roadmap for ATMPs
Speaker Presentation: CMC Strategy Forum Japan 2024
Francissen Kathleen, Genentech, A Member of the Roche Group, 2024 -
CMC Strategy Forum Japan 2024 Scientific Program
Scientific Program: CMC Strategy Forum Japan 2024
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CMC Strategy Forum Japan 2024 Summary Infographic
Summary Infographic: CMC Strategy Forum Japan 2024
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ICH Regulatory Updates and FDA Meetings - Lessons Learned
Speaker Presentation: WCBP 2024
Workshop ICH Regulatory Updates and FDA Meetings - Lessons Learned 2024 -
Comparability: Regulatory Considerations and Technical Challenges
Speaker Presentation: WCBP 2024
Workshop Comparability: Regulatory Considerations and Technical Challenges 2024