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CMC Strategy Forum Japan 2023 Scientific Program
Scientific Program: CMC Strategy Forum Japan 2023
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CMC Strategy Forum Japan 2023 Summary Infographic
Summary Infographic: CMC Strategy Forum Japan 2023
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CMC Strategy Forum Latin America 2023 Summary Infographic
Summary Infographic: CMC Strategy Forum Latin America 2023
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mRNA-launched Nanoparticle Vaccines
Speaker Presentation Carter Lauren University of Washington 2023
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BIONDDTM for Oral Delivery of Biologics –
The Future Delivery of Pharmaceuticals
Speaker Presentation Lindhardt Karsten Biograil 2023
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Stability Predictions for mAbs Using Arrhenius-Based Kinetics
Speaker Presentation Zidar Mitja Novartis Pharma AG 2023 -
Collaborative CMC Assessment of Post Approval Change Management Protocols: A Regulatory Health Authority-Perspective
Speaker Presentation Wilson Willie CBER, FDA 2023
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EFPIA Survey of EU Experience on Use of Quality Expedited Access (Including EU PRIME Toolbox) Tools
Speaker Presentation Wilkinson Diane AstraZeneca 2023
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Considerations for Potency Testing of mRNA Products
Speaker Presentation Widomski Pawel BioNTech 2023
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How to Connect Patient Centric Specifications with Immunogenicity of Biotherapeutics - A Regulator’s Perspective
Speaker Presentation Welin Mats Swedish Medical Products Agency 2023
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CMC Regulatory Considerations for Antibody-Drug Conjugates
Speaker Presentation Vriezen Nienke Byondis 2023
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Characterizing and Controlling Modes of Action - Critical Requirements for Potency Assays
Speaker Presentation Tomek Markus AGES, Austria 2023
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EMA Perspectives on International Convergence and Collaboration for CMC Submissions
Speaker Presentation Tiitso Klara European Medicines Agency 2023
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Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator's Perspective
Speaker Presentation Steffen Gross Paul-Ehrlich-Institut 2023
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In vitro Potency Assay for Follitropin alfa: A Case Study of Worldwide (Ongoing) Registration
Speaker Presentation Rochemont Morgane Merck & Co., Inc. 2023
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Leveraging Prior Knowledge to Support Early Phase Clinical Trial Applications: Regulatory CMC Considerations and Case Studies
Speaker Presentation Roberts Scott Novo Nordisk A/S 2023
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Advanced Kinetic Modelling - A Universal Tool for Stability Predictions of Biotherapeutics and Vaccines
Speaker Presentation Reddington Colm AstraZeneca 2023
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Advanced Kinetic Modelling: A Universal Tool for Stability Predictions of Biotherapeutics and Vaccines
Speaker Presentation Ramesh Sreejith Sanofi 2023
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In vitro Assessments of Immunogenicity
Speaker Presentation Morgan Hanna Novartis Pharma AG 2023
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Collaborative Approaches ICMRA Pilot on Collaborative Assessment of Post-Approval Change: Applicant's Experience
Speaker Presentation Meillerais Sylvie Merck Sharp & Dohme B.V. 2023