Resources
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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
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Overview of January 2020 CASSS Sharing Science Solutions Workshop on Established Conditions
Speaker Presentation Barnthouse Kristopher, Janssen, 2020
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ICH Q13 (Continuous Manufacturing) A Short Update
Speaker Presentation Nick Lee, HPRA-Health Products Regulatory Authority, 2020
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Drug Product Continuous Manufacturing DaurismoTM case study
Speaker Presentation Vanhooren Meike, Pfizer, 2020
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ICH Q2(R2)/Q14: Analytical Procedure Validation and Development – Status Update
Speaker Presentation Bream Robert, European Medicines Agency, 2020
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Application of Next Generation Sequencing to Biological and Biotechnological Products: How to Balance Regulation and Innovation
Speaker Presentation Genovese Domenico, National Centre for Control and Evaluation of Medicines (CNCF), 2020
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Analytical Bridging: How to Cross on the Wire Stretched Between Two Bioassay Methods?
Speaker Presentation Debauve Gael, UCB, 2020
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Bioassays Reflecting Fc Effector Functions – Selecting the Most Relevant Assay Type Considering the Molecules Mode of Action and the Assays Performance Characteristics
Speaker Presentation Holzmann Johann, Novartis, 2020
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The European Directorate for the Quality of Medicines & Healthcare (EDQM)
Speaker Presentation Buda Mihaela, EDQM, Council of Europe, 2020
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Strategies for Setting Patient-Centric Quality Standards
Speaker Presentation Mire-Sluis Anthony, AstraZeneca Inc., 2020