Resources
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CMC Strategy Forum Japan 2022 Scientific Program
Scientific Program: CMC Strategy Forum Japan 2022
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Targeted Revision of ICH Q1s/Q5C - Opportunities with Science and Risk-Based Approaches
Speaker Presentation Zimmerman Boris Genentech, a Member of the Roche Group 2022
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Industry Perspective on Polysorbate Degradation & Control Strategies for Biopharmaceutical Products - A View of EFPIA Working Group
Speaker Presentation Wuchner Klaus and Bechtold Peters Karoline Janssen 2022
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Viral Safety - Panel Discussion Questions 2022
Viral Safety - Panel Discussion Questions 2022
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Differences in Regulations on Gene Modified Organisms Between japan, Europe, and the United States
Speaker Presentation Tajima Gentaro Pfizer R&D Japan G.K. 2022
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Concept of the ICH-Q5A Second Revision
Speaker Presentation Sakurai Akira PMDA 2022
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Proteinaceous Visible Particle in Liquid Monoclonal Antibody Formulations
Speaker Presentation Saitoh Satoshi Chugai 2022
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Composition of the Application Material on Quality for the MAA of Regenerative Medical Products
Speaker Presentation Nishikawa Atsushi PMDA 2022
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Global Regulatory Considerations for
Allogeneic Cell Therapies
Speaker Presentation Momonoi Yoko Takeda Pharmaceuticals 2022
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China's Regulatory Framework for Biological
Products and the Latest Trend
Speaker Presentation Li Min Center for Drug Evaluation (CDE) 2022
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Regulatory Considerations for Moving from Emergency Use Authorization to Biological License Application for U.S. Products
Speaker Presentation Levis Robin CBER FDA 2022
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Using Stability Prior Knowledge From ‘Like-molecules’ to Determine Shelf-life
Speaker Presentation Lennard Andrew Amgen 2022
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An Industry Perspective on CHO Cell Product Virus Safety
Speaker Presentation Kobayashi Shohei Chugai 2022
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Points to Consider and Challenges in CMC for Regenerative Medical Products
Speaker Presentation Kitada Mitsuo and Hanada Naoyuki Novartis Pharma K.K. 2022
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PMDA Perspective on Visible Particles
in Biopharmaceuticals
Speaker Presentation Kishioka Yasuhiro PMDA 2022
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Regulatory Updates and a Perspective
on Biopharmaceuticals in Japan
Speaker Presentation Kishioka Yasuhiro PMDA 2022
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Current Status of GMO Regulation in Japan
Speaker Presentation Kanzaki Seiichi PMDA 2022
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Topics Regarding Revisions of ICH Q1/Q5C Guidelines: Focus on Biological Products
Speaker Presentation Kameda Takashi PMDA 2022
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EMA's Support to Innovation - A Status Update
Speaker Presentation Jekerle Veronika EMA 2022
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Rapid Detection of Viruses of Concern with Blazar® Platform - In Line with ICH Q5A(R2)
Speaker Presentation Feng Huixing Merck BioReliance 2022