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Welcome & Introduction to the EFPIA Manufacturing and Quality Expert Group (MQEG) -Biomanufacturing Satellite Session
Speaker Presentation Goese Markus F. Hoffmann-La Roche Ltd. 2023
Best Practices for Design and Performance of In-Use Stability and Compatibility Studies
Speaker Presentation Fast Jonas F. Hoffmann-La Roche Ltd. and Liu Jing Seagen Inc. 2023
Clinical Perspectives on Immunogenicity of Biotherapeutics
Speaker Presentation Deisenhammer Florian Innsbruck Medical University 2023
Moving from mAbs to rAAV: How Long Is the Journey to Assess Product Potency?
Speaker Presentation Debauve Gaël UCB Pharma S.A. 2023
Moving Towards ICH Q5A(R2): Use of Next Generation Sequencing for Viral Safety Testing of Biotechnology Products
Speaker Presentation Charbaut Taland Elodie Merck & Co., Inc. 2023
Using Platform Approaches with Vaccines to Support Rapid Development and Launch
Speaker Presentation Campa Cristiana GSK 2023
EFPIA Workstream on Agile Manufacturing - Transfer and Scale-up of Biologics Aseptic Manufacturing Processes Through Control Site Concept
Speaker Presentation Bechtold-Peters Karoline Novartis Pharma AG 2023
Global Perspective on Regulatory Reliance
Speaker Presentation Azatyan Samvel World Health Organization (WHO) 2023
Could One Size Fit All- Why Not?
Speaker Presentation Ayer Kavita Seagen Inc. 2023
Extending a Commercial Specification Beyond the Clinically Qualified Limits, How to Overcome the Challenges
Speaker Presentation Auquier Vanessa UCB Pharma S.A. 2023
Specifications and Lifecycle Management
Speaker Presentation Ahern Theresa Eli Lilly & Co. 2023
CMC Strategy Forum Europe 2023 Scientific Program
Scientific Program: CMC Strategy Forum Europe 2023
CMC Strategy Forum Europe 2023 Summary Infographic
Summary Infographic: CMC Strategy Forum Europe 2023
EMA Perspectives on International Convergence and Collaboration for CMC Submissions
Speaker Presentation Kotzagiorgis Evangelos EMA 2023
Genesis of ICH M4Q: From Inception to the Present Day
Speaker Presentation Markovic Ingrid CBER FDA 2023
The Revision of Brazilian Guidelines for Post-Approval Changes and Stability, and Its Impact on International Convergence in the Regulation of Biotechnological Products
Speaker Presentation Tavares Neto João ANVISA 2023
Post Approval Change Management - Global Harmonization Perspectives
Speaker Presentation Abdellah Hanane Merck KGaA 2023
CMC Latin America Session III 2023 Scientific Program
Scientific Program: CMC Latin America Session III 2023
CGE - Becoming the CE Expert in Your Organization – Best Practices Exchange
Roundtable 2 Notes: CE Pharm 2023
Cell Therapy CE Applications
Roundtable 3 Notes: CE Pharm 2023