FDA Commissioner Headlines Clinical Trials Symposium, September 14-15

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration, will be the keynote speaker at a clinical trials symposium, “Improving Clinical Research in the Age of Precision Medicine,” September 14 and 15 from 8 a.m. to 5 p.m., at the University of Miami BankUnited Center on the Coral Gables campus. UM President Julio Frenk will deliver the welcome address.

The symposium is being presented by the University of Miami Office of Research Compliance and Quality Assurance in collaboration with the FDA Offices of Regulatory Affairs and Minority Health. It will focus on scientific, regulatory and ethical aspects of clinical trials, as well as quality assurance practices. It will provide important updates on FDA regulatory requirements for clinical trials and perspectives from the front lines of clinical research.

Speakers from the University of Miami include Johanna Stamates, M.A., RN, Director of the Office of Research Compliance and Quality Assurance, Khemraj Hirani, Ph.D., M.Pharm., M.B.A., Associate Vice Provost for Human Subject Research, and Ann Glasse, M.B.A., RN, Director of Clinical Research Operations and Regulatory Support, and Assistant Director of the Clinical and Translational Science Institute Regulatory Program. Several FDA speakers are also on the program.

Registration for the two-day program, which includes at least 12 CEU credits, is $175. Registration and additional information are available here.

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