Resources
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The Journey to Commercialization
Speaker Presentation: CGTP Fall Virtual Summit 2024
Cross Scott, Dark Horse Consulting, 2024 -
Control Strategies Using CQAs for Method Changes and Comparability for Gene Therapy
Speaker Presentation: CGTP Fall Virtual Summit 2024
Ramsey Phillip, Sangamo Therapeutics, 2024 -
AAV Critical Quality Attributes: Comprehensive Analytical Control Strategies from Release to Characterization
Speaker Presentation: CGTP Fall Virtual Summit 2024
Powers Thomas, Pfizer Inc., 2024 -
Quality Attributes of rAAV-based Gene Therapy Medicinal Products
Speaker Presentation: CGTP Fall Virtual Summit 2024
Rodriguez Laura, AEMPS, 2024 -
CGTP Fall Virtual Summit 2024 Scientific Program
Scientific Program: CGTP Fall Virtual Summit 2024
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CGTP Fall Virtual Summit 2024 Summary Infographic
Summary Infographic: CGTP Fall Virtual Summit 2024
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I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' Network
Egodage Kamal, Lasanth Consulting, 2024 -
Operational Aspects of Medical Product Consulting
Speaker Presentation CASSS Consultants' Network
Moore Edwin, Biophia Consulting Inc., 2024 -
I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' Network
Cash Patricia, Independent Biotechnology Consultant, 2024 -
Alternative Microbiological Methods Implementation Case Study – BFPC
Speaker Presentation CMC Europe 2024
Vilgren Thais, Novo Nordisk A/S, 2024 -
Accelerating Sterility Testing: A Case Study on Implementing the 7-day Celsis Method
Speaker Presentation CMC Europe 2024
van den Berg Jonas, Roche Diagnostics Gmbh, 2024 -
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