Emergency Use Authorizations (EUAs) during the COVID-19 Pandemic

Kim Walker MS, RAC (US & EU), FRAPS; Global Regulatory, Quality and Clinical Consultant and Instructor, California State University at Fullerton and San Diego State University • Ms Walker is an independent Global Regulatory Affairs, Quality Assurance, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre postmarket regulatory, clinical, and quality system needs. Organization (WHO) as an Innovation COVIDShe is currently assisting the World Health and 19 Response Team Consultant. Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Ms. Walker has also participated in the San Diego Regulatory Affairs Network (SDRAN) Mentoring Program since 2009. She has achieved both the US and EU Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certifications. and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession. Kim is an instructor and co 

Kathleen Thoma, EdD, CCRC, CPH; Assistant Professor and Director of the Undergraduate Program in Clinical Research Administration, The George Washington University School of Medicine and Health Sciences • Dr. Thoma is an assistant professor in the Department of Clinical Research and Leadership and the program director for the undergraduate program in Clinical Research Administration. She has been at GW for almost 4 years. Before that, she was the director of research and a clinical research specialist at the University of Florida Center for HIV/AIDS Research, Education and Services for 10 years. During that time, she managed both industrysponsored and NIHfunded network trials through the IMPACT, HPTN, ATN and PHACS networks. She is a certified clinical research professional through the Society of Clinical Research Associates and is certified in public health. Her research interests include improving diversity in clinical trials, patient centricity and patient engagement in clinical trials, health literacy, health equity and HIV impacted populations.