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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, 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 Akunne, MPH
Chief, Project Management Staff, ORO, OND, 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
Panelist
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