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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 -
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
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CQA Risk Assessments for Cell and Gene Therapies
Roundtable 9 Notes: Cell & Gene Therapy Products 2023
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Comparability for Cell and Gene Therapy Products
Roundtable 3 Notes: Cell & Gene Therapy Products 2023
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CGTP 2023 Keynote Speaker Summary
Summary Simran Kaur CARGO Therapeutics, Inc.
Speaker Presentation Schweighardt Becky Grace Science LLC 2023 -
Accelerating CMC Review in PAC: ANVISA’s Online Optimized Assessment Project
Speaker Presentation Blades Carolina Brazilian Health Regulatory Agency (ANVISA) 2023
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Global Trends in Lifecycle Management
Speaker Presentation Hamel Hugo Health Canada 2023
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Reliance for Post-approval Changes: an Industry Perspective
Speaker Presentation Roman Maria Antoineta Latin American Federation of the Pharmaceutical Industry - FIFARMA 2023
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Analytics for Process-related Impurities in Viral Vector Manufacturing
Speaker Presentation Zilberman Alla Cygnus Technologies FDA 2023
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Regulatory Perspectives on Gene Therapies Incorporating Human Somatic Genome Editing
Speaker Presentation Ye Zhaohui FDA 2023
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Defining Microbial Control Strategies for Cell-Free and Cell-Based Individualized ATMPs
Speaker Presentation Von Wintzingerode Friedrich Genentech Roche 2023