Resources
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Marketing Authorization Assessment and GMP Inspection by the African Medicinces Agency (AMA) - CMC Experience From the Pilot Programme
Speaker Presentation: CMC Strategy Forum Europe 2025
Gram Oliver, Merck Sharp & Dohme (UK) Limited, 2025 -
Welcome & Introduction to the EFPIA Manufacturing and Quality Expert Group (MQEG) - Biomanufacturing Satellite Session
Speaker Presentation: CMC Strategy Forum Europe 2025
Goese Markus, F. Hoffmann-La Roche Ltd., 2025 -
Harnessing AI and Regulation
to Hyper Accelerate
Pharmaceutical R&D
Speaker Presentation: CMC Strategy Forum Europe 2025
Emili Luca, InsilicoTrials Technologies, 2025 -
Better Together: Reliance Practices at Swissmedic
Speaker Presentation: CMC Strategy Forum Europe 2025
Dalla Torre Simon, Swissmedic, 2025 -
Method Replacement: I Have a Bridge(ing) to Sell You
Speaker Presentation: CMC Strategy Forum Europe 2025
Chéry Cyrille C., UCB Pharma SA, 2025 -
Do We Worry Too Much About Polysorbate Degradation? - An Industry-Wide Perspective with Real Life Case Studies
Speaker Presentation: CMC Strategy Forum Europe 2025
Chéry Cyrille C., UCB Pharma SA, 2025 -
Bridging Aspects in Terms of Medical Devices – a Regulator’s Perspective
Speaker Presentation: CMC Strategy Forum Europe 2025
Buss Katrin, BfArM, 2025 -
Key Principles and Lifecycle Considerations for Pharmacopoeial Analytical Procedures
Speaker Presentation: CMC Strategy Forum Europe 2025
Buda Mihaela, European Directorate for the Quality of Medicines & Healthcare, 2025 -
In Vitro/in Vivo/in Silico Models to Support Bridging Strategies From SC to SC, From IV to SC and Vice Versa
Speaker Presentation: CMC Strategy Forum Europe 2025
Bruin Gerard, Novartis AG, 2025 -
Platform Method Applications – Leveraging Knowledge and Addressing Challenges
Speaker Presentation: CMC Strategy Forum Europe 2025
Bora Karina, Lonza Biologics, 2025 -
General Principles for Life-Cycle Management of Reference Standards
Speaker Presentation: CMC Strategy Forum Europe 2025
Bobinnec Yves, IPSEN, 2025 -
Prior and Platform Knowledge Use (Specifically Through a PTMF) in EU/EEA
Speaker Presentation: CMC Strategy Forum Europe 2025
Bilanin Mihai, GlaxoSmithKline, 2025 -
It’s All About Consistency: Change of Reference Standards for Potency Assessment in Clinical Phases
Speaker Presentation: CMC Strategy Forum Europe 2025
Beck Hermann, F. Hoffmann-La Roche Ltd., 2025 -
Subcutaneous Biologics: Advancing High-Concentration Technologies and Justifying CQA Specification Limits Through Translational Immunogenicity Models – Status Update
Speaker Presentation: CMC Strategy Forum Europe 2025
Bechtold-Peters Karoline, Novartis Pharma AG, 2025 -
ADCs and AxCs: Summary of a Recent EFPIA Member Survey on Antibody Conjugates
Speaker Presentation: CMC Strategy Forum Europe 2025
Bechtold-Peters Karoline, Novartis Pharma AG, 2025 -
Revolutionizing Regulatory Submissions Through Digital Innovation
Speaker Presentation: CMC Strategy Forum Europe 2025
Abernathy Michael, Amgen Inc., 2025 -
CMC Strategy Forum Europe 2025 Scientific Program
Scientific Program: CMC Strategy Forum Europe 2025
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CMC Strategy Forum Europe 2025 Summary Infographic
Summary Infographic: CMC Strategy Forum Europe 2025
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Streamlining Agile MS Workflows
with Genedata
Speaker Presentation: Mass Spec 2025
Cazy Aaron, Eli Lilly and Company, 2025 -
New Paradigm for Charge Variant Characterization Utilizing 'Discovery' Assisted Fractionation Strategy
Speaker Presentation: Mass Spec 2025
Xiao Yongsheng, WuXi Biologics, 2025