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Monday, June 28 • 1:00pm - 2:00pm
#111 SL: COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Jesper Kjær, MS

Speaker

DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Stine Hasling Mogensen, MPharm

Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Anton Pottegaard, DrSc, PhD, MPharm

Off-Label Use Monitoring Through Danish Registries
Mona Vestergaard Laursen, MPharm

FDA Real-World Evidence Activities Related to Covid19
Mitra Rocca, MSc

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
Richard Forshee, PhD


Speakers
avatar for Jesper Kjær

Jesper Kjær

Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre, Danish Medicines Agency (DKMA), Denmark
Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past... Read More →
avatar for Richard Forshee

Richard Forshee

Deputy Director, OBPV CBER, FDA, United States
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products... Read More →
avatar for Mona Vestergaard Laursen

Mona Vestergaard Laursen

Senior Advisor, Data Analytics Centre, Danish Medicines Agency, Denmark
SH

Stine Hasling Mogensen

Senior Scientific Advisor, Danish Medicines Agency, Denmark
Stine Mogensen holds a M.Sc. degree in Pharmacy (2010) and a PhD in Clinical Cancer Research, within drug development from Copenhagen University (2017). She has worked in the Danish Medicines Agency since 2017 and has been located in the Data Analytics Centre since 2019 after 2 years... Read More →
avatar for Anton Pottegaard

Anton Pottegaard

Head of Research at the Hospital Pharmacy; Professor, University of Southern Denmark, Denmark
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →

Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum