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Boston Convention and Exhibition Center

23 jun 2013 8:30 a.m. - 27 jun 2013 12:45 p.m.

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Session Chair(s)

Florence  Houn, MD, MPH, FACP

Florence Houn, MD, MPH, FACP

Consultant

Florence Houn MD MPH LLC, United States

Learning Objective : Discuss current Office of Minority Health initiatives in collaboration and advancing regulatory science; Identify expectations on industry for INDs and marketing applications regarding racial and ethnic enrollment into clinical trials, demographic analyses, and FDASIA requirements on FDA; Identify factors in addressing health disparities with global drug development.

Speaker(s)

Jonca  Bull, MD

The Challenge of the Generalizability of Clinical Data and Demographic Subgroups

Jonca Bull, MD

PPD, United States

Vice President, Regulatory Consulting

Lisa  LaVange, PHD

Regulatory Review Considerations for Demographic Subgroups: Representativeness and Interpretability of Results

Lisa LaVange, PHD

University of North Carolina at Chapel Hill, United States

Professor Emerita

Lisa  Egbuonu-Davis, MD, MBA, MPH

Leveraging Industry's Global Clinical Trials to Reduce Health Disparities Via Data Generation and Capacity Building

Lisa Egbuonu-Davis, MD, MBA, MPH

Danaher Diagnostics Platform, United States

VP Medical Innovations

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