Papers and Presentations
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You can search for a variety of content on the CASSS website. CASSS makes available any content with author approval. Narrow your search by using the various filters shown below, such as Resource Type, Event Type, and Year. Refine your search as needed.
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From Policies to Practices: Health Canada’s Approach to Modernization of CMC Review
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Speaker Presentation: CMC Strategy Forum North America 2026 SummerCherry Elana, Health Canada, 2026 -
The Need for Science and Risk-Based Approaches to Setting Specifications: A Regulatory Perspective
Speaker Presentation: CMC Strategy Forum North America 2026 SummerSmith Dean, Health Canada, 2026
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Predictive Stability for Biopharmaceuticals & Vaccines: Accelerating Patient Access through Industry Recommendations and Stakeholder Alignment
Speaker Presentation: CMC Strategy Forum North America 2026 SummerSkomski Daniel, Merck & Co., …
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Advancing Biomanufacturing and Regulatory Modernization: Innovation, Implementation, Operationalization
Speaker Presentation: CMC Strategy Forum North America 2026 SummerSiggers Richard, Health Canada, …
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Digital Innovation for Sustainable, Accelerated Development in an Era of Uncertainty
Speaker Presentation: CMC Strategy Forum North America 2026 SummerPapathanasiou Maria, Imperial College …
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Operationalizing Modern CMC Lifecycle Management: The Digital Infrastructure Behind Collaborative Regulatory Execution
Speaker Presentation: CMC Strategy Forum North America 2026 SummerNogueira Francisco, Accumulus …
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ICH Q14 Enhanced Approaches: From ATP to Analytical Procedure Validation Using Prior Knowledge and Development Data
Speaker Presentation: CMC Strategy Forum North America 2026 SummerMilford Mark, Eli Lilly and …
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Near-Concurrent Collaborative Reliance with Accumulus Technologies to Streamline Post-Approval Variations
Speaker Presentation: CMC Strategy Forum North America 2026 SummerKirwan J Paul, Amgen Inc., 2026
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ACCESS Worksharing Operational Insights and Process Optimization
Speaker Presentation: CMC Strategy Forum North America 2026 SummerHenry Sharlene, Sanofi Canada, …
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Beyond Borders: Scaling Biologics Post-Approval Changes Through Regulatory Reliance and Cloud-Based Digital Review
Speaker Presentation: CMC Strategy Forum North America 2026 SummerAiyer Kavita, Teva Pharmaceuticals …
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Survey on: Perceptions and Barriers Regarding Advanced Modelling and Adaptive Control Strategies
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/cmc-europe/2026/cmce_120x120_landing_r3.jpg?sfvrsn=d4a2ddfc_1)
Speaker Presentation: CMC Strategy Forum Europe 2026 Zahel Thomas, Koerber, 2026 -
Conjugates: Development Overview and Recent Discussions
Speaker Presentation: CMC Strategy Forum Europe 2026 Wan Kanny, Eli Lilly and Company, 2026
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ICH Q14 - a Regulatory View
Speaker Presentation: CMC Strategy Forum Europe 2026 van der Plas Martijn, Medicines Evaluation …
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WHO Guidelines on Procedures and Data Requirements for Changes to Approved Vaccines and Biotherapeutics: Recent Updates
Speaker Presentation: CMC Strategy Forum Europe 2026 Tesolin Lorenzo, Sciensano, 2026
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Regulatory Perspectives on Comparability Evaluation of Antibody-Drug Conjugates (ADCs)
Speaker Presentation: CMC Strategy Forum Europe 2026 Simek Pavel, SÚKL, 2026
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Predictive Stability Modelling: Health Canada's Risk Framework and Regulatory Readiness
Speaker Presentation: CMC Strategy Forum Europe 2026 Russell Paula, Health Canada, 2026
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Comparability Strategies for Bioconjugates
Speaker Presentation: CMC Strategy Forum Europe 2026 Pohl Thomas, Novartis Pharma AG, 2026
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Digital CMC Transformation Driven by Modelling and Agentic AI
Speaker Presentation: CMC Strategy Forum Europe 2026 Perea Velez Monica, GlaxoSmithKline, 2026
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Regulatory Challenges of Recent Low Endotoxin Recovery Queries
Speaker Presentation: CMC Strategy Forum Europe 2026 Peraino Jody, Pfizer, Inc., 2026
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Implementation of EU Variations Guidelines - EMA Perspective
Speaker Presentation: CMC Strategy Forum Europe 2026 Pedone Elisa, Paul-Ehrlich-Institut (PEI), 2026