Resources
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Commercial Process Control Strategy Considerations for Cell Therapy Products
Speaker Presentation Rajendran Saravanamoorthy, Bristol-Myers Squibb Company, 2020
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Regulatory Approaches for Accelerated Development in Europe
Speaker Presentation Welin Mats, Swedish Medical Products Agency, 2020
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Pandemic Preparedness: Regulatory Agility in the Era of COVID-19
Speaker Presentation Fernandes Jason, Health Canada, 2020
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Vaccine Development and Licensure Pathways: An Emerging Infectious Disease Vaccine Example
Speaker Presentation Levis Robin, CBER, FDA, 2020
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Expedited Programs and Challenges to Biologics Manufacturing
Speaker Presentation Kirshner Susan, CDER, FDA, 2020
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Update of Q12 Implementation in Japan
Speaker Presentation Yagi Satomi, Pharmaceuticals and Medical Devices Agency (PMDA), 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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Case Study: Industry Experience from PACMP Pilot Program in Japan
Speaker Presentation Kubodera Yoshinori, Chugai Pharmaceutical Co. Ltd., 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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Regulatory Approaches to CMC Development During COVID-19: Challenges and Opportunities
Speaker Presentation Shapiro Marjorie, CDER, FDA, 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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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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PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
Speaker Presentation Honda Futaba, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
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Digital Technology, an Assential Enabler to Meet the Burden of a Pandemic, and Beyond…
Speaker Presentation Lebreton Bénédicte, Genentech, a Member of the Roche Group, 2021
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Pre-License and Pre-Approval Inspections During the COVID-19 Pandemic
Speaker Presentation Peter Qiu Zhihao Peter, CDER, FDA, 2021
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Faster than Fast - Technology Transfer to Meet Demand for a Repurposed Biologic
Speaker Presentation Altenburger Ralf, F. Hoffmann - La Roche Ltd., 2021
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Broadening Narsoplimab Development from Orphan Indication to COVID-19 Treatment: CMC Regulatory Considerations
Speaker Presentation Harris Jonathan, Omeros Corporation, 2021
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Leveraging mRNA Platform Technologies to Enable Pandemic Supply of COVID-19 Vx
Speaker Presentation Combs Rodney, Pfizer Inc., 2021
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Racing to a SARS-CoV-2 Vaccine Using Platformtechnology
Speaker Presentation Hamaker Kent and Krishnan Mahesh, Merck & Co. Inc., 2021
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Use of Platform Analytical Methods to Accelerate Development and Commercialization of Theraputics Designed for Unmet Needs
Speaker Presentation Eris Tamer, Amgen Inc., 2021