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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 -
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
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Welcome & Introduction to the EFPIA Manufacturing and Quality Expert Group (MQEG) -Biomanufacturing Satellite Session
Speaker Presentation Goese Markus F. Hoffmann-La Roche Ltd. 2023
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Best Practices for Design and Performance of In-Use Stability and Compatibility Studies
Speaker Presentation Fast Jonas F. Hoffmann-La Roche Ltd. and Liu Jing Seagen Inc. 2023
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Clinical Perspectives on Immunogenicity of Biotherapeutics
Speaker Presentation Deisenhammer Florian Innsbruck Medical University 2023
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Moving from mAbs to rAAV: How Long Is the Journey to Assess Product Potency?
Speaker Presentation Debauve Gaël UCB Pharma S.A. 2023
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Moving Towards ICH Q5A(R2): Use of Next Generation Sequencing for Viral Safety Testing of Biotechnology Products
Speaker Presentation Charbaut Taland Elodie Merck & Co., Inc. 2023
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Using Platform Approaches with Vaccines to Support Rapid Development and Launch
Speaker Presentation Campa Cristiana GSK 2023
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EFPIA Workstream on Agile Manufacturing - Transfer and Scale-up of Biologics Aseptic Manufacturing Processes Through Control Site Concept
Speaker Presentation Bechtold-Peters Karoline Novartis Pharma AG 2023