
Resources
-
Biophysical Characterization and Control of AAV Using Multi-Attribute Methods
Speaker Presentation: CGTP Europe 2025
Hibbins Angus, Johnson & Johnson Innovative Medicine, 2025 -
Potency Assurance in Cell Therapy: Bridging Theory and Practice
Speaker Presentation: CGTP Europe 2025
Heemskerk Matthias, Galapagos NV, 2025 -
Adapting the Principles of Comparability Assessments for Complex ATMPs
Speaker Presentation: CGTP Europe 2025
Francissen Kathleen, Genentech, a Member of the Roche Group, 2025 -
Evaluating Sequencing Strategies for ATMP Genomic Risk Assessment
Speaker Presentation: CGTP Europe 2025
Buzatu Rafaella, Medicines Evaluation Board, 2025 -
Characterising Viral Vectors for Gene Therapy Delivery Using Mass Spectrometry on Different Levels
Speaker Presentation: CGTP Europe 2025
Bones Jonathan, NIBRT, 2025 -
CGTP Europe 2025 Summary Infographic
Summary Infographic: CGTP Europe 2025
-
CGTP Europe 2025 Scientific Program
Scientific Program: CGTP Europe 2025
-
Establishment of Robust Compendial Methods for Analysis of Monoclonal Antibody Products
Speaker Presentation: CMC Strategy Forum Europe 2025
Vesterinen Jaana, Finnish Medicines Agency, 2025 -
Reliance as an Essential Tool to Promote Efficient and Robust Global Regulatory Oversight
Speaker Presentation: CMC Strategy Forum Europe 2025
Valentin Marie, World Health Organization, 2025 -
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