Resources
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International Cooperation and Reliance in Practice
Speaker Presentation: CMC Strategy Forum Latin America 2025
Harvey Martin, European Medicines Agency (EMA), 2025 -
Development of ICH M4Q(R2) Common Technical Document on Quality - Guideline Update
Speaker Presentation: CMC Strategy Forum Latin America 2025
Hamel Hugo, Health Canada, 2025 -
Roche’s Second EMA WHO PAC Reliance Project
Speaker Presentation: CMC Strategy Forum Latin America 2025
Espinola Victoria, Roche International Ltd., 2025 -
Biologic Product Review Through Reliance: A Chilean Pilot
Speaker Presentation: CMC Strategy Forum Latin America 2025
Bori Francisco, Public Health Institute of Chile (ISPCH), 2025 -
Bridging Innovation and Access: Advancing Regulatory Capacity and AI-Driven Drug Development
Speaker Presentation: CMC Strategy Forum Latin America 2025
Auclair Jared, Northeastern University, 2025 -
Innovative Digital Regulatory Transformation: The First Cloud-based Submission
Speaker Presentation: CMC Strategy Forum Latin America 2025
Abernathy Michael, Amgen Inc., 2025 -
Best Practices for In-Use Stability and Compatibility Studies
Summary Papers: CMC Strategy Forum North America 2024
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“Catch Me if You Can” Analytical Considerations for the Control of Multi-Specific Antibody (MsAb) Homodimer Impurities
Speaker Presentation: CMC Strategy Forum North America 2025
Zhang Fang, Pfizer, Inc., 2025 -
Navigating the Regulatory Landscape for Multispecifics & Bioconjugates
Speaker Presentation: CMC Strategy Forum North America 2025
Yeung Angela, Health Canada, 2025 -
Regulatory Considerations in the Design, Development and Quality of Monoclonal Antibodies and Related Novel Antibody-Based Products
Speaker Presentation: CMC Strategy Forum North America 2025
Shapiro Marjorie, CDER, FDA (Retired), 2025 -
Control Strategies for Radiobioconjugates
Speaker Presentation: CMC Strategy Forum North America 2025
Raghunandan Gowri, Fusion Pharma, 2025 -
A QbD Approach for Analytical Comparability of ADC Molecule
Speaker Presentation: CMC Strategy Forum North America 2025
Liu Ally, Gilead Sciences, Inc., 2025 -
The “5C” Network of Linker-Payloads: Chemistry, Conjugation, Characterization, and Control of the Cytotoxic Intermediate
Speaker Presentation: CMC Strategy Forum North America 2025
Kovacs Ernest, Immunome Inc., 2025 -
CMC Considerations For Bioconjugates and Multispecifics: A Regulator′s Perspective
Speaker Presentation: CMC Strategy Forum North America 2025
Goto Kanoko, Pharmaceuticals and Medical Devices Agency (PMDA), 2025 -
Antibody-Drug Conjugates: Regulatory Insights and Lessons Learned
Speaker Presentation: CMC Strategy Forum North America 2025
Duncan Katharine K, GlaxoSmithKline, 2025 -
From Complexity to Clarity: Chile's Regulatory Vision for Bioconjugates & Multispecifics
Speaker Presentation: CMC Strategy Forum North America 2025
Canales Jorge, Public Health Institute of Chile, 2025 -
CMC Strategy Forum North America 2025 Summer Scientific Program
Scientific Program: CMC Strategy Forum North America 2025 Summer
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CMC Strategy Forum North America 2025 Summer Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2025 Summer
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CGTP 2025 Summary Infographic
Summary Infographic: CGTP 2025
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Use of New Rapid Sterility Testing Methods – Successes and Challenges
Roundtable Notes: Session 1 Table 8 CGTP 2025
Use of New Rapid Sterility Testing Methods – Successes and Challenges