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Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment
Program Code:
376
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Florence Houn,
MD,MPH,FACP (SCHNON),
FDA Alumni Association; Celgene, United States
Dr. Florence Houn is co-chair of the FDA Alumni Association's International Network. She works at Celgene Corporation of Summit, NJ, as Vice President for Regulatory Policy and Strategy. Prior to that, she was at the Food & Drug Administration at various leadership positions in CDER, CBER, and CDRH.
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SPEAKER
(S):
Jonca C. Bull,
MD (SPKAGY), Director, Office of Minority Health, Office of the Commissioner,
FDA, United States
Dr. Bull serves as a Vice President in US Drug Regulatory Affairs at Novartis. Dr. Bull worked at the Food and Drug Administration from 1994 to 2006
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Lisa M. LaVange, PhD (SPKAGY), Director, Office of Biostatistics, Office of Translational Science, CDER, FDA, United States
Lisa Egbuonu-Davis,
MD,MBA,MPH (SPKNON), Co-Founder, Director, ROI Squared LLC,
ROI Squared LLC, United States
Experience pharmaceutical executive with training in medicine, public health, comparative effectiveness research.
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Description
This session will identify expectations of industry for INDs and marketing applications regarding racial and ethnic enrollment into clinical trials, demographic analyses, and FDAISA requirements on FDA. It will also discuss policy implications for global development, health disparities, and meaningful inclusion of demographic subgroups (sex, race, ethnicity, age) and current Office of Minority Health initiatives in collaboration and advancing regulatory science.