Papers and Presentations
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You can search for a variety of content on the CASSS website. CASSS makes available any content with author approval. Narrow your search by using the various filters shown below, such as Resource Type, Event Type, and Year. Refine your search as needed.
Transforming Global Regulatory CMC Practices
"Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation" features a panel of esteemed regulatory experts, including representatives from ANVISA, US FDA, EMA, PMDA, and WHO, who share their invaluable insights on global harmonization. View the Plenary Session
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Establishment of Specifications for Monoclonal Antibodies
Speaker Presentation: CMC Strategy Forum Japan 2024Yu Chuanfei, NIFDC, 2024
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ICH Q6 Revision Towards Globally Harmonized Specifications
Speaker Presentation: CMC Strategy Forum Japan 2024Yamaguchi Takahiro, JPMA, 2024
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Challenges in the Clinical Implementation of piggyBac Transposon Mediated CAR-T Cell Therapy
Speaker Presentation: CMC Strategy Forum Japan 2024Yagyu Shigeki, A-SEEDS, 2024
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Role of ICH Q2/Q14 and ICH Q6 on Establishment of Control Strategy
Speaker Presentation: CMC Strategy Forum Japan 2024Shibata Hiroko, PMDA, 2024
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Regulatory Updates and a Perspective on Biopharmaceuticals in Japan
Speaker Presentation: CMC Strategy Forum Japan 2024Sakurai Akira, PMDA, 2024
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Expectations for ICH M4Q(R2) from an Industry Point of View
Speaker Presentation: CMC Strategy Forum Japan 2024Ohtsuka Hiroshi, Bayer Yakuhin, Ltd., 2024
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Quality Control of the Raw Materials for Cell and Gene Therapy Products
Speaker Presentation: CMC Strategy Forum Japan 2024Nishikawa Atsushi, PMDA, 2024
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Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Speaker Presentation: CMC Strategy Forum Japan 2024Markovic Ingrid, CBER, FDA, 2024 [Session IV]
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ICH Efforts Towards Developing a Unified ICH Q6 Guideline and Modernizing Global Standards for Specifications Setting
Speaker Presentation: CMC Strategy Forum Japan 2024Markovic Ingrid, CBER, FDA, 2024 [Session III]
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Update on the Initiatives at the Center for Biologics Evaluation and Research (CBER), U.S. FDA
Speaker Presentation: CMC Strategy Forum Japan 2024Markovic Ingrid, CBER, FDA, 2024 [Session I]
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Update on ICH M4Q(R2)
Speaker Presentation: CMC Strategy Forum Japan 2024Kishioka Yasuhiro, PMDA, 2024
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ICH Cell & Gene Therapy Discussion Group: Progress Toward Delivering a Strategic Roadmap for ATMPs
Speaker Presentation: CMC Strategy Forum Japan 2024Francissen Kathleen, Genentech, A Member of the Roche …
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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 2024Workshop ICH Regulatory Updates and FDA Meetings - Lessons Learned …
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Comparability: Regulatory Considerations and Technical Challenges
Speaker Presentation: WCBP 2024Workshop Comparability: Regulatory Considerations and Technical Challenges …
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In-use Stability Study Design: A Regulatory Perspective
Speaker Presentation: WCBP 2024Russell Paula, Health Canada, 2024
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Disruptive Innovation in Drug Development and Personalized Medicine: Human Organ Chips and Beyond
Speaker Presentation: WCBP 2024Ingber Don, Wyss Institute for Biologically Inspired Engineering, Harvard …
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CQAs and Strategies to Accelerate the Development of Gene Therapies
Speaker Presentation: CGTP Fall Virtual Summit 2024Campbell Catherine, 4D Molecular Therapeutics, …
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The Journey to Commercialization
Speaker Presentation: CGTP Fall Virtual Summit 2024Cross Scott, Dark Horse Consulting, 2024