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Regulatory Advances in Post Approval Changes of Biological Products in Peru
Speaker Presentation Torres Cinthia, General Directorate of Medicines, Supplies and Drugs - Peru, 2024 -
Approaches to Design an Efficient, Predictable Global Post‑approval Change Management System that Facilitates Continual Improvement and Product Availability
Speaker Presentation Ramnarine Emabelle, Boehringer Ingelheim, 2024
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Ignite the Future - Our Exciting PAC Reliance Journey with 48 NRAs
Speaker Presentation Mangia Francesca, F. Hoffmann-La Roche Ltd, 2024
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Regulatory Convergence in Latin America: Overcoming Challenges in Post-Registration
Speaker Presentation Taroco de Almeida Patricia, Eurofarma, 2024
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CMC Strategy Forum Latin America 2024 Scientific Program
Scientific Program: CMC Strategy Forum Latin America 2024
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CMC Strategy Forum Latin America 2024 Summary Infographic
Summary Infographic: CMC Strategy Forum Latin America 2024
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Common Gaps in BLA Packages for QC Release and Stability Method Validations
Speaker Presentation Ritter Nadine, Global Biotech Experts, LLC, 2024 -
CMC Strategy Forum North America July 2024 Summary Infographic
Summary Infographic: CMC Strategy Forum North America July 2024
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Honing Analytical Methods for Next Generation ADCs
Speaker Presentation Wang Chunlei, AstraZeneca, 2024
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Regulatory Considerations for Bioconjugates from the Small Molecule Perspective
Speaker Presentation Wan Kanny, CDER, FDA, 2024
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Overview of the Landscape of Bioconjugates: Emerging Applications and Design Considerations
Speaker Presentation Ross-Holz Emily, Genentech, a Member of the Roche Group, 2024
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CMC Regulatory Considerations for Antibody-Drug Conjugates
Speaker Presentation Morgan Charles, Denali Therapeutics, 2024
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Antibody Drug Conjugates - Requirements for Characterization and Control of ADCs from a (European) Regulator's Perspective
Speaker Presentation Merz Christian, Paul-Ehrlich-Institut, 2024
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Bioconjugates: Navigating the Regulatory Landscape
Speaker Presentation Jules Felix, Health Canada, 2024
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Understanding Impurities in Antibody Conjugates
Speaker Presentation Jeffery Carroll, Avidity Biosciences, 2024
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Control Strategies for Potency
Speaker Presentation James David, Merck & Co., Inc., 2024
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Considerations for Developing Oligonucleotide Transport Vehicle Conjugates
Speaker Presentation Adams Amelia, Denali Therapeutics, 2024
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CMC Strategy Forum North America July 2024 Scientific Program
Scientific Program: CMC Strategy Forum North America July 2024
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Comparability for Cell and Gene Therapy Products
Summary Paper: CGTP Summit 2023
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Plenary Session 4 - Potency Assays for Gene Edited Products Summary
Speaker Presentation Pannullo Nicole Plenary Session 4 Summary 2024