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Overview of January 2020 CASSS Sharing Science Solutions Workshop on Established Conditions
Speaker Presentation Barnthouse Kristopher, Janssen, 2020
ICH Q13 (Continuous Manufacturing) A Short Update
Speaker Presentation Nick Lee, HPRA-Health Products Regulatory Authority, 2020
Drug Product Continuous Manufacturing DaurismoTM case study
Speaker Presentation Vanhooren Meike, Pfizer, 2020
ICH Q2(R2)/Q14: Analytical Procedure Validation and Development – Status Update
Speaker Presentation Bream Robert, European Medicines Agency, 2020
Application of Next Generation Sequencing to Biological and Biotechnological Products: How to Balance Regulation and Innovation
Speaker Presentation Genovese Domenico, National Centre for Control and Evaluation of Medicines (CNCF), 2020
Analytical Bridging: How to Cross on the Wire Stretched Between Two Bioassay Methods?
Speaker Presentation Debauve Gael, UCB, 2020
Bioassays Reflecting Fc Effector Functions – Selecting the Most Relevant Assay Type Considering the Molecules Mode of Action and the Assays Performance Characteristics
Speaker Presentation Holzmann Johann, Novartis, 2020
The European Directorate for the Quality of Medicines & Healthcare (EDQM)
Speaker Presentation Buda Mihaela, EDQM, Council of Europe, 2020
Strategies for Setting Patient-Centric Quality Standards
Speaker Presentation Mire-Sluis Anthony, AstraZeneca Inc., 2020
Establishment of Patient Centric Quality Standards: Monoclonal Antibody Cast Studies
Speaker Presentation Rellahan Barbara, Amgen, 2020
Establishing Patient Centric Quality Standards: Cell & Gene Therapy Case Studies
Speaker Presentation Roberts Matthew, C&GT Analytical Development - GSK, 2020
Patient-centric Specifications for Cell & Gene Therapy Products: Maximizing Patient Access to Safe & Effective Quality Product
Speaker Presentation Riker Kenneth, Bristol Myers Squibb, 2020
COVID-19 Vaccine Urgency Throws Spotlight on Next-Generation Sequencing for Adventitious Virus Control Japan
CMC Summary Paper: CMC Strategy Forum Japan 2020
Summary of 2016 CASSS CMC Strategy Forum Japan
CMC Summary Paper: CMC Strategy Forum Japan 2016
Summary of 2015 CMC Strategy Forum Japan
CMC Summary Paper: CMC Strategy Forum Japan 2015
Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan
CMC Summary Paper: CMC Strategy Forum Japan 2014
Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum
CMC Summary Paper: CMC Strategy Forum Japan 2013
Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree
CMC Summary Paper: CMC Strategy Forum Japan 2012
COVID-19 Vaccine Urgency Throws Spotlight on Next-Generation Sequencing for Adventitious Virus Control Europe
CMC Summary Paper: CMC Strategy Forum Europe 2020
EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment
CMC Summary Paper: CMC Strategy Forum Europe 2019