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Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar

Webinar #1:

Advancing COVID-19 Data Science and Bioinformatic Methods

12:00 – 1:30 P.M. ET
Tuesday, May 18, 2021

Webinar #2

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

Caleb Alexander

G. Caleb Alexander, MD, MS

Introduction and Moderator
Johns Hopkins University
Mitra Rocca

Mitra Rocca, PhD

Speaker #1
Food and Drug Administration
Chris Chute

Chris Chute, MD, PhD

Speaker #2
Johns Hopkins University
Jeremy Rassen

Jeremy Rassen, ScD

Speaker #3
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

Richardae Araojo

Rear Admiral Richardae Araojo, PharmD

Introduction
Food and Drug Administration
Jessica Mega

Jessica Mega, MD

Speaker #1
Verily
Donna Rivera

Donna Rivera, PharmD, MS

Speaker #2
Food and Drug Administration
Brian Garibaldi

Brian Garibaldi, MD

Speaker #3
Johns Hopkins University
Jodi Segal

Jodi Segal, MD, MPH

Moderated Discussion
Johns Hopkins University

Contact

For questions and concerns, please email Jamie Heyward at jheywar1@jhu.edu.