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Virtual

Dec 08, 2021 9:50 AM - Dec 09, 2021 4:30 PM

(US Eastern Standard Time)

Diagnostics and Personalized Medicine Conference

This event is now offered in a new entirely virtual format.

Session 6: COVID Diagnostic Tests Lessons Learned

Session Chair(s)

Susan  Tiedy-Stevenson, MS

Susan Tiedy-Stevenson, MS

Senior Director

Hogan Lovells US LLP, United States

This session is intended to provide an interactive discussion with the top leaders from FDA Center for Devices and Health as well as from the Reagan-Udall Foundation for the FDA, a leading academic scholar who has worked on public health strategies during the COVID-19 pandemic, a former FDA leader previously involved with other declared emergency situations and a well-known attorney that has worked with many companies in successful obtaining marketing authorizations for diagnostics.

The goals of this session are to provide stakeholders with an understanding of the flexibility that FDA has exercised during the pandemic in authorizing tests, continuous tracking of tests performance; compliance issues, and how the interactive engagement with test developers has resulted in ensuring devices that are safe and effective for their intended use. Explore whether this flexibility may shape or influence regulatory development of non-Covid-19 assays that meet public health needs in personalized medicine and companion diagnostics. You will also hear the views from those in the public health sector and those working with industry on lessons learned in response to the pandemic.

Learning Objective :
  • Recognize the regulatory flexibility implemented by the FDA to ensure the availability of safe and effective diagnostic assays
  • Discuss the FDA’s current thinking on how regulatory flexibility used during the COVID-19 pandemic may or may not apply to non-COVID-19 assays
  • Apply information from the interactive panel discussion to non-COVID-19 assay regulatory development strategies
  • Discuss the lessons learned from the challenges of the pandemic

Speaker(s)

Jeffrey  Shuren, JD, MD

Speaker

Jeffrey Shuren, JD, MD

FDA, United States

Director, Center for Devices and Radiological Health

Timothy  Stenzel

Speaker

Timothy Stenzel

FDA, United States

Director, Office of In Vitro Diagnostics and Radiological Health, CDRH

Amanda  Kobokovich

Speaker

Amanda Kobokovich

Johns Hopkins University, United States

Research Associate

Susan  Winckler, JD, RPh

Speaker

Susan Winckler, JD, RPh

Reagan-Udall Foundation For the FDA, United States

Chief Executive Officer

Alberto  Gutierrez, PhD

Speaker

Alberto Gutierrez, PhD

NDA Partners, United States

Partner

Randy Julius Prebula, JD

Speaker

Randy Julius Prebula, JD

Hogan Lovells US LLP, United States

Partner

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