Resources
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Leveraging AI and Machine Learning in Pharmaceutical Manufacturing: Opportunities, Risks, and Regulatory Considerations
Speaker Presentation CMC Europe 2024
Thurau Gert, F. Hoffman-La Roche Ltd., 2024 -
Use of Prior Knowledge and Platform Approaches: An EU Regulatory Perspective
Speaker Presentation CMC Europe 2024
Shivji Ragini, European Medicines Agency, 2024 -
Examples of ML and AI in Manufacturing: Formufilling Digital Twin and Automated Visual Inspection
Speaker Presentation CMC Europe 2024
Popkin Matt, GlaxoSmithKline, 2024 -
Enabling Platform Technologies: an Industry Perspective on Enabling Platforms and Prior Knowledge
Speaker Presentation CMC Europe 2024
Popkin Matt, GlaxoSmithKline, 2024 -
Regulatory Reliance in LCM: A Reality, Not Just a Dream?
Speaker Presentation CMC Europe 2024
Pellett Mark, AstraZeneca, 2024 -
One Voice of Quality (1VQ) for PACs & Practical Experience With PACMP
Speaker Presentation CMC Europe 2024
Metzner Beatrix, Boehringer Ingelheim Pharma GmbH & Co. KG, 2024 -
Agile Manufacturing Concepts and the Role of the Qualified Person in Draft EU General Pharma Legislation
Speaker Presentation CMC Europe 2024
Kurz Andrea, Roche Diagnostics Gmbh, 2024 -
Demonstrating Comparability of AAV Gene Therapy Products: Application of Lessons Learned
Speaker Presentation CMC Europe 2024
Kinsella Niamh, Biogen, 2024 -
ICH Q12: Experience From PLCM Submissions
Speaker Presentation CMC Europe 2024
Ho Kowid, F. Hoffman-La Roche Ltd., 2024 -
Introduction to the EFPIA Manufacturing and Quality Expert Group (MQEG) - Biomanufacturing WG Satellite Session 2024
Speaker Presentation CMC Europe 2024
Goese Markus, F. Hoffman-La Roche Ltd., 2024 -
Use of Multi-Attribute-Method by Mass Spectrometry as a QC Release and Stability Tool for Biopharmaceuticals – the EFPIA Perspective
Speaker Presentation CMC Europe 2024
Gervais Annick, UCB Pharma S.A., 2024 -
Multiproduct Resin Reuse (MRR) Strategy in Clinical Development
Speaker Presentation CMC Europe 2024
Frey Claudia, Merck Sharp & Dohme UK Limited, 2024 -
Use of Third Party Prior Knowledge and Platform Data
Speaker Presentation CMC Europe 2024
Ford Gair, AstraZeneca, 2024 -
Regulating AI in Drug Manufacturing
Speaker Presentation CMC Europe 2024
Fisher Adam, CDER, FDA, 2024 -
EU GMPs Annex 1: 2022 - New Role of the Microbiologists on Aseptic Processes
Speaker Presentation CMC Europe 2024
Dalmaso Gilberto, GDM Pharma Consulting, 2024 -
Application of ICH Q2/Q14 to Procedure Development and Changes for Monoclonal Antibodies and Gene Therapy Products
Speaker Presentation CMC Europe 2024
Chéry Cyrille, UCB Pharma S.A., 2024 -
PACMPs: Best Practices, and Future Opportunities
Speaker Presentation CMC Europe 2024
Chauhan Vandana, Gilead Sciences, Inc., 2024 -
Navigating Challenges in Subcutaneous Biologics: Advancing High and Ultra-High Concentration Technologies with a Patient-Centric Approach
Speaker Presentation CMC Europe 2024
Bechtold-Peters Karoline, Novartis Pharma AG, 2024 -
Industry Perspective on the Use of Post-Approval Change Management Protocol
Speaker Presentation CMC Europe 2024
Basu Sen Shrobona, Novo Nordisk A/S, 2024 -
Rethinking Biosimilar Approval: A Future Without Phase 3 Trials?
Speaker Presentation CMC Europe 2024
Barry Sean, Health Products Regulatory Authority, 2024