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Webcast: A Conversation with FDA Commissioner Dr. Stephen M. Hahn: The FDA EUA Process for COVID-19 Vaccines and Testing

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RAC Credits
Tuesday, 17 November 2020 (1:00 PM) - Tuesday, 17 November 2020 (2:00 PM) Eastern Time (US & Canada)

Tuesday, 17 November 2020 • 1:00–2:00 PM Eastern Time (US & Canada)

This is a special event exclusively for RAPS members. This webcast will be live only and will not be recorded or available for future viewing.

Not a member? Do not miss the opportunity to connect with Dr. Stephen Hahn and hear the latest vital information from the FDA. Join the RAPS membership community to attend this and future sessions from notable health authorities.

Join Us

 

The COVID-19 pandemic has fostered innovation in the regulatory and decision-making processes at the US Food and Drug Administration (FDA) and prompted sponsors to adopt new product development approaches to confront unique challenges.

Join Dr. Stephen Hahn, Commissioner of Food and Drugs, at the US FDA and members of FDA leadership for a discussion focused on the Emergency Use Authorization (EUA) processes for both COVID-19 testing and vaccines.

 

This discussion will be moderated by RAPS board members:


Jethro Ekuta
Vice President
Global Regulatory Affairs & US Lead
Alexion Pharmaceuticals, Inc.

 

Carol Cooper
Principal Consultant
CM Cooper and Associates

 

This session will address:

  • What the agency is doing to ensure an objective and science-based regulatory approach that will encourage the public to take authorized or approved vaccines.
  • How the agency is ensuring that drugs and vaccines meet a set of minimum criteria for a EUA to increase the likelihood of eventual approval by the agency.
  • The current views of the FDA regarding EUA authorized tests and their fate after the public health emergency (PHE).
  • How the agency is preparing for the next PHE and how industry can assist FDA in the process.