Resources
-
ICH M4Q(R2) - Revision Overview and Regulatory Perspectives
Speaker Presentation: CMC Strategy Forum Europe 2025
Tiitso Klara, European Medicines Agency, 2025 -
Design and CMC Considerations for Oligo-Functionalized Antibodies: The Case of Brainshuttle™-ASO Conjugates
Speaker Presentation: CMC Strategy Forum Europe 2025
Schumacher Felix, F. Hoffmann-La Roche Ltd., 2025 -
MAIT Engagers: Safer T-Cell Engagers With a Large Therapeutic Window for the Treatment of Cancer
Speaker Presentation: CMC Strategy Forum Europe 2025
Plyte Simon, Biomunex Pharmaceuticals, 2025 -
Impact, Opportunities and Challenges Transitioning to CMC Structured Data Submissions in the Cloud
Speaker Presentation: CMC Strategy Forum Europe 2025
Palacios Rodrigo, F. Hoffmann-La Roche AG, 2025 -
Novel Aspects of the M4Q(R2) and Industry Perspectives
Speaker Presentation: CMC Strategy Forum Europe 2025
Nielsen Henrik K., Novo Nordisk A/S, 2025 -
A Streamlined Approach for Low-Risk, Multi-Site Regulatory Submissions: The ‘Sister Site’ Concept
Speaker Presentation: CMC Strategy Forum Europe 2025
Lennard Andrew, Amgen Limited, 2025 -
Trends for CMC Post-Approval Change Review Time: 2018-2024
Speaker Presentation: CMC Strategy Forum Europe 2025
Karim Kacimi, Novo Nordisk A/S, 2025 -
Lifecycle Management of Reference Standards Post-Commercialization: Case Studies and Best Practices
Speaker Presentation: CMC Strategy Forum Europe 2025
Jiménez Ramírez Carmilia, Miliar Biopharma Solutions, 2025 -
Considerations for Platform Analytical Procedures
Speaker Presentation: CMC Strategy Forum Europe 2025
Ho Kowid, F. Hoffmann-La Roche Ltd., 2025 -
EMA Regulatory Update Rapid Fire Session
Speaker Presentation: CMC Strategy Forum Europe 2025
Ho Kowid, F. Hoffmann-La Roche Ltd., 2025 -
Challenges of Multispecific Antibodies From the Reviewers Perspective
Speaker Presentation: CMC Strategy Forum Europe 2025
Gross Steffen, Paul-Ehrlich-Institut, 2025 -
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