Federal Register Notice: FDA’s Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development will hold a two-day public workshop 9/12-13 entitled “Pediatric Clinical Investigator Training.” Its purpose is 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: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
The workshop will be held from 8 a.m. to 4 p.m. at the DoubleTree Bethesda, 8120 Wisconsin Ave., Bethesda, MD. Contact Terrie L. Crescenzi, terrie.crescenzi@fda.hhs.gov; or Betsy Sanford, elizabeth.sanford@fda.hhs.gov. To view this notice, click here.