Resources
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Bioassay Evolution – Where Are We Now?
Speaker Presentation Mire-Sluis Anthony, AstraZeneca, 2021
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Potency Assays for Engineered Cell Therapies
Speaker Presentation Lowe Emily, Kite, a Gilead Company, 2021
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The Power of Proper System Suitability Tests - A Case Study of cGMP Method Improvement
Speaker Presentation Li Ruojia, Bristol-Myers Squibb Company, 2021
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Development of a New Cell Adhesion Bioassay Format
Speaker Presentation Kröner Frieder, Novartis Pharma KG, 2021
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Potency Assay Strategy for a Fixed-Dose Combination Product
Speaker Presentation Avenal Cécile, F. Hoffmann - La Roche AG, 2021
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Enhancing the Speed of Vaccine Development by Utilizing Fullt Automated High Throughput Cell Potency Assays
Speaker Presentation Acevedo-Skrip Jillian, Merck & Co. Inc., 2021
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PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
Speaker Presentation Honda Futaba, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Communications, Regulatory Flexibilities and Quality Challenges for Biologics in the COVID19 Pandemic: An EMA Perspective
Speaker Presentation Shivji Ragini, European Medicines Agency, 2020
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Regulatory Challenges: Expediting CMC Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2020
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Regulatory Approaches to CMC Development During COVID-19: Challenges and Opportunities
Speaker Presentation Shapiro Marjorie, CDER, FDA, 2020
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ICH Q12 Update and Reflections on the USFDA Established Conditions Pilot Program
Speaker Presentation Welch Joel, CDER, FDA, 2020
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Case Study: Industry Experience from PACMP Pilot Program in Japan
Speaker Presentation Kubodera Yoshinori, Chugai Pharmaceutical Co., Ltd., 2020
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Introduction of post-approval change management protocol (PACMP) mock-up in Japan preparation
Speaker Presentation Funato Keiko, GlaxoSmithKline K.K., 2020
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Update of Q12 Implementation in Japan - Japan
Speaker Presentation Yagi Satomi, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Medical Products Agency and the biotech arena in Sweden
Speaker Presentation Welin Mats Barbu Andreea, Andreea Barbu, Swedish Medical Products Agency, 2020
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Multi-company Survey on the Use and Characterization of Polysorbates in Biotech Products
Speaker Presentation Wuchner Klaus, Janssen Pharmaceutical R&D, LLC, 2020
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CMC Regulatory Considerations for ADCs
Speaker Presentation Bechtold-Peters Karoline, Novartis, 2020
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Manufacturing Challenges of AAV Gene Therapy Products
Speaker Presentation Legmann Rachel, Pall Corporation, 2020
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Quality of AAV Gene Therapy Products from a Regulator's view
Speaker Presentation Mück Christoph, AGES-Austrian Agency for Health and Food Safety, 2020
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ICH Q12 EU implementation (+ Q5A / Quality Discussion Group status update)
Speaker Presentation Kruse Nanna, Danish Medicines Agency, 2020