The first FDA Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), with support from the National Institutes of Health, is now open for registration. The course will be held on November 16 and 17, from 8 a.m. to 5 p.m. and on November 18, from 8 a.m. to 3:30 p.m. at the National Labor College, 10000 New Hampshire Avenue, Silver Spring, Maryland 20903.

This intensive, three-day course will enable clinical investigators to gain a greater appreciation of the scientific, ethical, and regulatory issues relating to clinical trial data that may be submitted to regulatory bodies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research.

Topics to be discussed include the design, conduct, and analysis of clinical trials; regulatory considerations essential for clinical research; the role of the DSMB and IRB in clinical studies; preclinical and pharmacological issues in clinical studies; safety assessment during clinical trials; inclusion of special populations such as pregnant women in clinical studies; and the role of personalized medicine in the future of medical product development. The course has been designed with the goal of enabling investigators to improve the quality of clinical trials and to enhance the safety of trial participants.

Course Fee: US$ 300.00

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