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The Future of Regulatory Submission and Assessment: Impact of Digitalization
Speaker Presentation Yu Lawrence CDER, FDA 2023 -
Reliance - Towards a Global Regulatory Standard
Speaker Presentation Tami Cecilia Genentech, a Member of the Roche Group 2023
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A Framework for Ensuring Quality with Patient-Centric Specifications
Speaker Presentation Schofield Tim CMC Sciences LLC 2023
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Modeling for Product-specific Stability: A Regulatory Perspective
Speaker Presentation Russell Paula Health Canada 2023
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Predictive Stability Methodologies: The Why, When and What
Speaker Presentation Rellahan Barbara Amgen 2023
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Bayesian Statistics: Using Prior Knowledge to Enhance Understanding of Product-Specific Stability
Speaker Presentation Rauk Adam Eli Lilly and Company 2023
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The Genesis of M4Q(R2): A Regulatory Perspective
Speaker Presentation Markovic Ingrid CBER, FDA 2023
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Making Harmonization a Reality
Speaker Presentation Lee Kathy Genentech, a Member of the Roche Group 2023
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Patient Focused Specifications
Speaker Presentation Kirshner Susan CDER, FDA 2023
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What Was Gained and Lost with the Harmonization of Specifications with COVID-19 Vaccines
Speaker Presentation Fernandes Jason Health Canada 2023
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Perspective for Modernization of Regulatory Assessment and Submission Including KASA and PQ/CMC
Speaker Presentation Damdinsuren Bazarragchaa CDER, FDA 2023
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ISO/IDMP Initiative: Maturing Structure and Standardization within the Healthcare Ecosystem
Speaker Presentation Casselberry Brooke NNIT 2023
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The Future of Real-time Algorithmic Exchange and Processing of CMC Data Using FHIR
Speaker Presentation Anderson Craig Pfizer, Inc. 2023
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CMC North America July 2023 Scientific Program
Scientific Program: CMC North America July 2023
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Higher Order Structure 2022 Summary Infographic
Summary Infographic: Higher Order Structure 2022
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Bridges Strategies for Manufacturing and CQA Assay Changes Moving Phase 1 to Phase 2 Focus – from Phase 1/2 to Pivotal
Roundtable 12 Notes: Cell & Gene Therapy Products 2023 -
CMC Latin America Session I 2023 Scientific Program
Scientific Program: CMC Latin America Session I 2023
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Stability Testing
Roundtable 5 Notes: Cell & Gene Therapy Products 2023
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Process Development of a Cell or Gene Therapy - Speed to a Phase 1 FIH Clinical Supply - Best Practices or Lessons Learned
Roundtables 4 and 2 Notes: Cell & Gene Therapy Products 2023
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Potency Assays
Roundtable 1 Notes: Cell & Gene Therapy Products 2023