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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
- 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)

Panelist
Linda C Akunne, MPH
- Chief, Project Management Staff, ORO, CDER
- FDA, United States

Panelist
Kathryn Ramseyer, PharmD
- Senior Director, Global Regulatory Affairs-North America
- Eli Lilly and Company, United States
Panelist
Ashley Rhoades, MS, RAC
- Senior Manager, Regulatory Affairs
- Gilead Sciences, Inc., United States