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Thursday, July 1 • 2:00pm - 3:00pm
#441 SL: Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-663-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will discuss managing emergency use authorizations in a complex world. The value of communication and continuous learning in emergency regulatory science.

Learning Objectives

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.

Chair

Terrell Baptiste, MBA

Speaker

Panelist
Linda C Akunne, MPH

Panelist
Kathryn Ramseyer, PharmD

Panelist
Ashley Rhoades, MS, RAC


Speakers
TB

Terrell Baptiste

Associate Director, Regulatory Policy and Intelligence, Gilead Sciences, Inc., United States
Terrell Baptiste, Regulatory Policy and Intelligence, Gilead Sciences represents the Regulatory Affairs and Development organization to support and advise regulatory strategies that leverage innovative regulatory programs. He has a track record of successfully forging collaborations... Read More →
LA

Linda Akunne

Chief, Project Management Staff, ORO, CDER, FDA, United States
Linda C. Akunne is a Chief, Project Management Staff in the Division of Regulatory Operations for Infection Diseases in CDER's Office of New Drugs. In this role, Linda provides technical direction, oversight, and leadership to the DROID staff on the drug review process for antiviral... Read More →
KR

Kathryn Ramseyer

Senior Director, Global Regulatory Affairs-North America, Eli Lilly and Company, United States
avatar for Ashley Rhoades

Ashley Rhoades

Senior Manager, Regulatory Affairs, Gilead Sciences, Inc., United States
RAC-credentialed regulatory affairs professional with experience in the biopharmaceutical industry, primarily in Emerging Viruses and most recently with COVID-19 therapeutics. Degrees include a B.S. in Biomathematics from Loyola Marymount University and a Masters of Business and Science... Read More →

Thursday July 1, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum