Resources
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A Critical Review of the Final EMA Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes in Drug Development
Speaker Presentation Schiestl Martin, Sandoz GmbH, 2021
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Interfaces - Clinical Trials, Assays, and In-vitro-diagnostics
Speaker Presentation Reischl Ilona, AGES MEA, 2021
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Considerations on Multi-Attribute-Method (MAM) by LC-MS as QC Tool
Speaker Presentation Pohl Thomas, Novartis Pharma AG, 2021
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Successful Notified Body Opinion and Marketing Authorization Application, and an Approach to Life Cycle Management
Speaker Presentation Mingam Isabelle, UCB Farchim SA, 2021
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Revised EMA Reflection Paper: 'Similarity Condition' and 'Similarity Criterion' as Two Separate Aspects for the Comparison of Quality Attributes Data
Speaker Presentation Lang Thomas, AGES MEA, 2021
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Regulatory Considerations on mRNA Products in Cancer Therapy
Speaker Presentation Hoefnagel Marcel, MEB-Medical Evaluations Board, 2021
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Rapid Sterility Testing
Speaker Presentation Guest Miriam, AstraZeneca, 2021
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Welcome & Introduction to EFPIA MQEG Biomanufacturing Satellite Session
Speaker Presentation Goese Markus, F. Hoffmann-La Roche Ltd, 2021
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ICH Q9 Risk Management Practical Applications for ATMPs - An AAV Case Study
Speaker Presentation Cowgill Cynthina, BioMarin Pharmaceutical, Inc., 2021
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Monitoring Clearance of Lipase Host Cell Proteins in mAb Manufacturing Using an LC-MS/MS Quantitation Method
Speaker Presentation Chen Rachel, Biogen, 2021
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A Risk-Based Approach to the Determination of the Control System for an AAV-based Gene Therapy Product
Speaker Presentation Challand Andrea, F. Hoffmann-La Roche Ltd, 2021
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Notified Bodies and Their Roles in Assessing Quality of Drug Delivery Devices
Speaker Presentation Caro-Barri Julia Slides, Notified Body No. 0318, based at the Spanish Medicines Agency (AEMPS), 2021
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Challenges of Formulation of mRNA Products
Speaker Presentation Borchard Gerrit, University of Geneva, 2021
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Agile (aka Autonomous & Portable) Manufacturing with Specific Focus on Aseptic Modular Chamber
Speaker Presentation Bechtold-Peters Karoline, Novartis Pharma AG, 2021
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Application of Quality Risk Management to an Oncolytic Virus, IMLYGIC® (talimogene aherparepvec)
Speaker Presentation Anderson Brian, Amgen Inc., 2021
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Troubleshooting Report - CZE and CE-SDS the Discussion Continues
CZE and CE-SDS the Discussion Continues -
Troubleshooting Report - cIEF and materials for CZE
cIEF and materials for CZE
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Troubleshooting Report - Ghostly Peaks and other Haunting Aberrations in CE
Ghostly Peaks and other Haunting Aberrations in CE
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Troubleshooting Report - CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks
Troubleshooting CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks
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Stability Considerations and Challenges in Autologous Cell Therapy
Speaker Presentation Polson Nolan, Bristol-Myers Squibb Company, 2020