Resources
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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
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Considerations on CMC Review for Blood Products
Speaker Presentation Jia Dongchen CDE 2022
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Welcome CMC China 2022
Speaker Presentation Edwards Julia Genentech CMC China 2022
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Multiple Manufacturing Sites
Speaker Presentation Goering Brad Sanofi 2022
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Patient-Centric Innovation to Modernize the Development
and Manufacture of Biologics
Speaker Presentation Chen Yan Roche 2022
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Using Prior Knowledge and Accelerated CMC Tools to Support Early Access to Medicines
Speaker Presentation Barry Sean HPRA CMC Slides 2022
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EMA Perspectives on ICH M4Q(R2) and Digital Regulatory Assessment
Speaker Presentation Tiitso Klara EMA 2022
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SubQ Bioavailability Considerations
Speaker Presentation Sanchez-Felix Manuel Novartis 2022
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Platform Protocol Templates: An Innovative Upcoming Tool for Comparability Assessment and Process Validation
Speaker Presentation Rovira Olga CEPI 2022
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QIG Overview
Speaker Presentation Popkin Matthew GSK plc 2022