Resources
-
Communications, Regulatory Flexibilities and Quality Challenges for Biologics in the COVID19 Pandemic: An EMA Perspective
Speaker Presentation Shivji Ragini, European Medicines Agency, 2020
-
PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
Speaker Presentation Honda Futaba, Pharmaceuticals and Medical Devices Agency (PMDA), 2020
-
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
-
Pre-License and Pre-Approval Inspections During the COVID-19 Pandemic
Speaker Presentation Peter Qiu Zhihao Peter, CDER, FDA, 2021
-
Faster than Fast - Technology Transfer to Meet Demand for a Repurposed Biologic
Speaker Presentation Altenburger Ralf, F. Hoffmann - La Roche Ltd., 2021
-
Broadening Narsoplimab Development from Orphan Indication to COVID-19 Treatment: CMC Regulatory Considerations
Speaker Presentation Harris Jonathan, Omeros Corporation, 2021
-
Leveraging mRNA Platform Technologies to Enable Pandemic Supply of COVID-19 Vx
Speaker Presentation Combs Rodney, Pfizer Inc., 2021
-
Racing to a SARS-CoV-2 Vaccine Using Platformtechnology
Speaker Presentation Hamaker Kent and Krishnan Mahesh, Merck & Co. Inc., 2021
-
Use of Platform Analytical Methods to Accelerate Development and Commercialization of Theraputics Designed for Unmet Needs
Speaker Presentation Eris Tamer, Amgen Inc., 2021
-
Impact of COVID-19 on Next Generation Sequencing Applications for Adventitious Virus Detection in Vaccine Manufacturing
Speaker Presentation Khan Arifa, CBER, FDA, 2021
-
Academic Knowledge & Innovation to Accelerate Successful
Technological Transfer for a COVID-19 Vaccine
Speaker Presentation Bottazzi Maria Elena, Baylor College of Medicine, 2021
-
Production of Anti-Coronavirus Disease 2019 Hyperimmune
Globulin from COVID-19 Convalescent Plasma
Speaker Presentation Willis Todd, Grifols, 2021
-
Building COVID-19 Testing Capacity from Scratch
Speaker Presentation Storgaard Guldberg Torben, Novo Nordisk A/S, 2021
-
Emergency Use Diagnostics in a Pandemic: A Global Perspective
Speaker Presentation Miller Danelle, Roche Diagnostics, 2021
-
The Role of Emergency Use Authorization (EUA) in Coivd-19 Diagnostics
Speaker Presentation Karsner Ryan, CDRH, FDA, 2021
-
Clinical Development of COVID-19 Vaccines
Speaker Presentation Krause Philip, CBER, FDA, 2021
-
Global Comparability/Characterization Strategy for NVX-CoV2373
Speaker Presentation Schenerman Mark, Novavax Inc., 2021
-
Overview of Cross-company (Trade Associations) Discussion on CMC Approaches to Support Development and Supply of COVID Vaccines
Speaker Presentation Campa Cristiana, GlaxoSmithKline, 2021
-
Engineering Cell Lines for AAV Cell-based Potency Assays
Speaker Presentation Whipple Stephanie, Genzyme, a Sanofi Company, 2021
-
Bioassays as Part of an Integrated Control Strategy
Speaker Presentation Van der Plas Martijin, Medical Evaluations Board (MEB), 2021