Resources
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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
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ICH Q5A (R2) Expansion of Scope to Include Viral Vectors
Speaker Presentation Chénard Gilles Janssen 2022
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Application and Challenge of Advanced Therapy Medical Products (ATMP)
Speaker Presentation Xu Longchang CDE 2022
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Technical Requirements for Viral Safety Control of Recombinant Biotechnology Products
Speaker Presentation Sai Wenbo CDE 2022
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Classification and Technical Requirements of CMC Changes of Biological Products
Speaker Presentation Qiu Xiao CDE 2022
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Strategies for Management of Manufacturing Process for Blood Products
Speaker Presentation Podrygajlo Grzegorz CSL Behring 2022
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Post-Approval Changes, Change Management Protocols and Comparability for ATMPs
Speaker Presentation Niederlaender Christiane Paraxel Internation 2022
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Regulatory Requirements
and Case Sharing on Post
Approval Change
Management Protocol
Speaker Presentation Nielsen Henrik Novo Nordisk 2022
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Introduction to Prophylactic Vaccines and Clinical Studies
Speaker Presentation Liu Bo 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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Updates and a Perspective on ICH Q12 Implementation in Japan
Speaker Presentation Kishioka Yasuhiro Pharmaceuticals and Medical Devices Agency 2022
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Introduction to the Technical Requirements in the Guidelines on Prophylactic COVID-19 mRNA Vaccines
Speaker Presentation Jin Su CDE 2022