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DIA 2021 Global Annual Meeting

Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned

Session Chair(s)

Terrell Baptiste, MBA

Terrell Baptiste, MBA

  • Associate Director, Regulatory Policy and Intelligence
  • Gilead Sciences, Inc., United States
This forum will discuss managing emergency use authorizations in a complex world. The value of communication and continuous learning in emergency regulatory science.
Learning Objective : Describe the elements of Emergency Use Authorizations (EUA); Identify case studies underscoring the process for issuing EUAs; Discuss engagement i.e., meetings and communications with regulators/sponsors when requesting an EUA; Describe how the EUA process differs from: expanded access and clinical trials under INDs and NDAs.

Speaker(s)

Linda C Akunne, MPH

Panelist

Linda C Akunne, MPH

  • Chief, Project Management Staff, ORO, CDER
  • FDA, United States
Kathryn Ramseyer, PharmD

Panelist

Kathryn Ramseyer, PharmD

  • Senior Director, Global Regulatory Affairs-North America
  • Eli Lilly and Company, United States
Ashley Rhoades, MS, RAC

Panelist

Ashley Rhoades, MS, RAC

  • Senior Manager, Regulatory Affairs
  • Gilead Sciences, Inc., United States