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COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches
Session Chair(s)
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk A/S, Denmark
This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.
Learning Objective : Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.
Speaker(s)
Stine Hasling Mogensen, MPHARM
Senior Scientific Advisor, Danish Medicines Agency, Denmark
DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Anton Pottegaard, DRSC, PHD, MPHARM
Head of Research at the Hospital Pharmacy; Professor, University of Southern Denmark, Denmark
Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Mona Vestergaard Laursen, MPHARM
Senior Advisor, Data Analytics Centre, Danish Medicines Agency, Denmark
Off-Label Use Monitoring Through Danish Registries
Mitra Rocca, MSC
Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
FDA Real-World Evidence Activities Related to Covid19
Richard Forshee, PHD
Associate Director of Benefit Risk Assessment, OSE, CDER, FDA, United States
COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
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