Resources
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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 -
In-use Stability Study Design: A Regulatory Perspective
Speaker Presentation: WCBP 2024
Russell Paula, Health Canada, 2024 -
Disruptive Innovation in Drug Development and Personalized Medicine: Human Organ Chips and Beyond
Speaker Presentation: WCBP 2024
Ingber Don, Wyss Institute for Biologically Inspired Engineering, Harvard University, 2024 -
CQAs and Strategies to Accelerate the Development of Gene Therapies
Speaker Presentation: CGTP Fall Virtual Summit 2024
Campbell Catherine, 4D Molecular Therapeutics, 2024 -
The Journey to Commercialization
Speaker Presentation: CGTP Fall Virtual Summit 2024
Cross Scott, Dark Horse Consulting, 2024 -
Control Strategies Using CQAs for Method Changes and Comparability for Gene Therapy
Speaker Presentation: CGTP Fall Virtual Summit 2024
Ramsey Phillip, Sangamo Therapeutics, 2024 -
AAV Critical Quality Attributes: Comprehensive Analytical Control Strategies from Release to Characterization
Speaker Presentation: CGTP Fall Virtual Summit 2024
Powers Thomas, Pfizer Inc., 2024 -
Quality Attributes of rAAV-based Gene Therapy Medicinal Products
Speaker Presentation: CGTP Fall Virtual Summit 2024
Rodriguez Laura, AEMPS, 2024 -
CGTP Fall Virtual Summit 2024 Scientific Program
Scientific Program: CGTP Fall Virtual Summit 2024
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CGTP Fall Virtual Summit 2024 Summary Infographic
Summary Infographic: CGTP Fall Virtual Summit 2024
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I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' Network
Egodage Kamal, Lasanth Consulting, 2024 -
Operational Aspects of Medical Product Consulting
Speaker Presentation CASSS Consultants' Network
Moore Edwin, Biophia Consulting Inc., 2024 -
I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' Network
Cash Patricia, Independent Biotechnology Consultant, 2024 -
Alternative Microbiological Methods Implementation Case Study – BFPC
Speaker Presentation CMC Europe 2024
Vilgren Thais, Novo Nordisk A/S, 2024 -
Accelerating Sterility Testing: A Case Study on Implementing the 7-day Celsis Method
Speaker Presentation CMC Europe 2024
van den Berg Jonas, Roche Diagnostics Gmbh, 2024