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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
CMC Priorities of EFPIA’s European Biopharmaceutical Enterprises Include ADCs, Drug/Device Combos and Statistics
CMC Summary Paper: CMC Strategy Forum Europe 2018
Accelerated Development and Review Initiatives in Focus at 2016 CASSS CMC Strategy Forum Europe
CMC Summary Paper: CMC Strategy Forum Europe 2016
Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing
CMC Summary Paper: CMC Strategy Forum Europe 2014
EMA's Key Biotech Quality Initiatives in Focus at CASSS' 2012 CMC Strategy Forum Europe
CMC Summary Paper: CMC Strategy Forum Europe 2012
Improving Biopharmaceutical Product Quality: Moving Implementation Forward
CMC Summary Paper: CMC Strategy Forum Europe 2011
Challenges Facing Biopharmaceutical Development in the Next Decade
CMC Summary Paper: CMC Strategy Forum Europe 2010
Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says
CMC Summary Paper: CMC Strategy Forum Europe 2010 - 2
Protein Quality and Binding Affinities by Affinity CE and 2-dimensional Separations
Speaker Presentation Wätzig Hermann, University of Braunschweig, 2020
Tapping Into New Applications Using Automated Protein Mass Spectrometry
Speaker Presentation Völger Hans-Rainer, Roche Diagnostics GmbH, 2020