Papers and Presentations
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To PACMP or Not to PACMP
![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)
Roundtable Notes: Table 2 CMC Strategy Forum Europe 2026 To PACMP or Not to PACMP -
The MDR Regulation Including the Latest Updates
Roundtable Notes: Table 8 CMC Strategy Forum Europe 2026 The MDR Regulation Including the Latest …
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Targeted Radiopharmaceuticals
Roundtable Notes: Table 1 CMC Strategy Forum Europe 2026 Targeted Radiopharmaceuticals
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Risk Based Approaches in CMC Filing for Biological Products
Roundtable Notes: Table 9 CMC Strategy Forum Europe 2026 Risk Based Approaches in CMC Filing for Biological …
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Predictive Stability Modelling – Current State and Best Practice
Roundtable Notes: Table 4 CMC Strategy Forum Europe 2026 Predictive Stability Modelling – Current …
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New EU Variation Classification - Experience to Date
Roundtable Notes: Table 3 CMC Strategy Forum Europe 2026 New EU Variation Classification - Experience …
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New EU Pharma Legislation
Roundtable Notes: Table 6 CMC Strategy Forum Europe 2026 New EU Pharma Legislation
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GMP Inspection Roundtable – Key Takeaways for Regulatory Affairs CMC
Roundtable Notes: Table 5 CMC Strategy Forum Europe 2026 GMP Inspection Roundtable – Key Takeaways …
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Expedited Approvals of Medicines for Rare Diseases
Roundtable Notes: Table 10 CMC Strategy Forum Europe 2026 Expedited Approvals of Medicines for Rare …
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Survey on: Perceptions and Barriers Regarding Advanced Modelling and Adaptive Control Strategies
Speaker Presentation: CMC Strategy Forum Europe 2026 Zahel Thomas, Koerber, 2026
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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
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The EU Quality Innovation Group Perspective on Modelling and AI in Pharmaceutical Process Development and Manufacturing
Speaker Presentation: CMC Strategy Forum Europe 2026 Martinez-Peyrat Leticia, French National Agency …