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MS of RNA and Oligonucleotides: Characterization and Quantitation of PQAs
Roundtable 4 Notes: Mass Spectrometry 2023 -
End to End Automation: Sample Prep to Data Analysis for MS Workflows
Roundtable 2 Notes: Mass Spectrometry 2023
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Best Practices for Sequence Variant Analysis
Roundtable 5 Notes: Mass Spectrometry 2023
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Best Practices for Predicting, Elucidating and Monitoring Hotspots by MS
Roundtable 8 Notes: Mass Spectrometry 2023
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HOS 2023 Scientific Program
Scientific Program: HOS 2023
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Mass Spec 2022 Scientific Program
Scientific Program: Mass Spec 2022
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Mass Spec 2023 Scientific Program
Scientific Program: Mass Spec 2023
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CMC Latin America Session II 2023 Scientific Program
Scientific Program: CMC Latin America Session II 2023
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Overview of ICH Q2(R2)/Q14:
Development and Validation of Analytical Procedures
Speaker Presentation Cauchon Nina Amgen Inc. and Pelletier Mary Beth Biogen 2023 -
CMC North America July 2023 Summary Infographic
Summary Infographic: CMC North America July 2023
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WCBP 2023 Scientific Program
Scientific Program: WCBP 2023
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The Future of Regulatory Submission and Assessment: Impact of Digitalization
Speaker Presentation Yu Lawrence CDER, FDA 2023
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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