This activity is intended for physicians, pharmacists, nurses, researchers and others who are responsible for the conduct of clinical trials.
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2019 Pediatric Clinical Investigator Training Workshop
The 2019 Pediatric Clinical Investigator Training Workshop will take place on February 28, 2019 from 8:00 a.m. to 5:00 p.m. The event will be held in the Great Room (Bldg 31), Room 1503A, of the U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. There is no cost to attend in-person or remotely, but all participants must register.
The workshop is intended to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with a clear understanding of some of the challenges of studying products in the pediatric population, including: pediatric study designs, use of extrapolation, dose selection, pediatric subpopulations (including neonates), development of biomarkers and endpoints, ethical considerations, development of pediatric friendly formulations and safety data collection.
Additional details, including a full agenda, will be announced soon.
Registration is now open.