Papers and Presentations
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Application and Challenge of Advanced Therapy Medical Products (ATMP)
![System.Collections.Generic.List`1[System.String] Thumbnail](http://www.casss.org/images/default-source/cmc-china/cmcc2022_120x120_landing_new.jpg?sfvrsn=24d4d585_3)
Speaker Presentation Xu Longchang CDE 2022 -
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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Ervebo® vaccine for Ebola virus – a case study on approaches to accelerate process development and tech transfer
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/cmc-china/cmcc2022_120x120_landing.jpg?sfvrsn=494543c5_3)
Speaker Presentation Califano Joseph, Merck & Co. Inc., 2021 -
COVID Vaccines: Expediting Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2021
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CMC Considerations From Development Through Registration of An Autologous CAR-T Therapy
Speaker Presentation Gillet Delphine, Novartis Pharma AG, 2021
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Vector-based ATMP Development in the EU Regulatory and Scientific Considerations
Speaker Presentation Reischl Ilona, AGES MEA, 2021
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Regulatory Considerations for CAR T Cell Development
Speaker Presentation Schultz Kimberly, CBER, FDA, 2021
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For 2021 meetings, content will be available for one year after the program. For 2022 and beyond, content will be available for three months.