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Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned
Session Chair(s)
Terrell Baptiste, MBA
Director, Regulatory Policy ,Regulatory Affairs
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 Akunne, MPH
FDA, United States
Chief, Project Management Staff, ORO, OND, CDER
Panelist
Kathryn Ramseyer, PHARMD
Eli Lilly and Company, United States
Senior Director, Global Regulatory Affairs-North America
Panelist
Ashley Rhoades, MS, RAC
Gilead Sciences, Inc., United States
Senior Manager, Regulatory Affairs