Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar
Advancing COVID-19 Data Science and Bioinformatic Methods
12:00 – 1:30 P.M. ET
Tuesday, May 18, 2021
Using Informatics to Advance Use, Safety, and Effectiveness of COVID-19 Medical Products
12:00 – 1:30 P.M. ET
Tuesday, May 25, 2021
Hosted by Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) and the Food and Drug Administration
About the Webinar Series
The coronavirus disease 2019 (COVID-19) pandemic is a health crisis of unprecedented scale. While there are many facets to an effective response, clinical informatics can assist regulators, policy makers and other stakeholders in optimizing medical product use and value. Drawing on the experience of nationally renowned clinicians, scientists and regulatory experts, and sponsored by the U.S. Food and Drug Administration and the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI), this two-part webinar will provide a stimulating and timely analysis of the use of clinical informatics in optimizing the regulatory and public health response to the COVID-19 pandemic in the United States.
Agenda & Speakers
Webinar #1: Advancing COVID-19 Data Science and Bioinformatic Methods
This 90-minute webinar will focus on the science of informatics as it applies to advancing COVID research. Particular emphasis will be given to the topics including the development of registries to capture the patient journey, strategies to link registry data with information from laboratories, biospecimens and other clinical repositories, use of common data models to support data standardization and harmonization and enhancing the application of unstructured learning as a means to accelerate knowledge generation.
Speakers
G. Caleb Alexander, MD, MS
Johns Hopkins University
Mitra Rocca, PhD
Food and Drug Administration
Chris Chute, MD, PhD
Johns Hopkins University
Jeremy Rassen, ScD
Aetion
Webinar #2: Using Informatics to Advance Use, Safety, and Effectiveness of COVID-19 Medical Products
This 90-minute webinar will focus on the applied use of informatics to examine COVID-19 medical product evaluation. Particular emphasis will be given to knowledge dissemination about therapeutics, devices and diagnostics covered under Emergency Use Authorizations and approaches to rapidly generate new insights regarding SARS-CoV-2 infection, including among racial and ethnic minorities, pregnant women, children and the elderly.
Speakers
Rear Admiral Richardae Araojo, PharmD
Food and Drug Administration
Jessica Mega, MD
Verily
Donna Rivera, PharmD, MS
Food and Drug Administration
Brian Garibaldi, MD
Johns Hopkins University
Jodi Segal, MD, MPH
Johns Hopkins University
Contact
For questions and concerns, please email Jamie Heyward at jheywar1@jhu.edu.