Resources
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Accelerating Global Supply of Vaccines –Lessons Learnt
Speaker Presentation Pellet Mark AstraZeneca 2022
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Regulatory Experience from the Rolling Review Process and the Conditional Marketing Authorisation Process for COVID-19 Vaccines
Speaker Presentation Pedone Elisa European Medicines Agency 2022
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The Case for Revision to the ICH Stability Guidelines: An Industry Perspective
Speaker Presentation Lennard Andrew Amgen Inc. 2022
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Transmission Electron Microscopy - Utilising a Powerful Tool in Biosafety as a Novel Approach
Speaker Presentation Layland Ashely neotem Bioanalytics 2022
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The Future is Now: ICH Q14: Analytical Procedure Development ICH Q2(R2): Validation of Analytical Procedures
Speaker Presentation Keire David CDER, FDA 2022
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Strategies of Overcoming Risks of Changing Analytical Methods
Speaker Presentation Gellermann Gerald Novartis 2022
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Capillary Electrophoresis and Taylor Dispersion Analysis for the Characterization of mRNA Vaccines
Speaker Presentation Cottet Hervé IBMM, Université de Montpellier 2022
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Development of New Ph. Eur. “Horizontal Standards” for Monoclonal Antibody Analysis: An Overview from the EDQM
Speaker Presentation Buda Mihaela EDQM 2022
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Cutting-Edge Multi-Level Analytical and Structural Characterization of Antibody-Based Therapeutics
Speaker Presentation Beck Alain Pierre Fabre Group 2022
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Biological Reference Standards for Multivalent Vaccines - Qualification, Strategies and Challenges From a National Control Lab Perspective
Speaker Presentation Tesolin Lorenzo Sciensano 2020
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Double Duty Bioassays: A Regulatory
Perspective on Bispecific Antibody
Bioassay Development
Speaker Presentation Nickens Kristen US FDA 2020
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Development and Qualification of a Potency Assay to Support Gene Therapy
Speaker Presentation Maheno Hannah Sanofi 2020
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Flow into the Future - The Importance of Flow Cytometry Methods in Engineered T Cell Therapies
Speaker Presentation Lowe Emily Kite 2020
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Moroccan Good Regulatory Practices: Regulatory and Technical Requirements for the Registration of Medicines for Human Use in Morocco
Speaker Presentation Lakhlili Wiame DMP 2020
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A Shared Framework for Protein Analytics; Bioassays Enhancing Drug Development
Speaker Presentation Kozlowski Steven CDER FDA 2020
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Curve Similarity Index for Testing Parallelism in Bioassay
Speaker Presentation Faya Paul Eli Lilly 2020
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Critical Reagents in Bioassay - Their Importance, Characterization and Storage
Speaker Presentation Asara Nana Charles River Laboratories 2020
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The USP Bioassay Chapters: Out with the Old, In with the New
Speaker Presentation Walfish Steven USP 2019
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Performing Bioassays - an OMCL Point-of-view
Speaker Presentation Vesterinen Jaana Finnish Medicines Agency 2019
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Bioassay Development for Complex Biologics: A Case Study for a Prodrug
Speaker Presentation Swiss Victoria Bristol-Myers Squibb 2019