Scheduled for Thursday, Feb. 28, 2019, the Pediatric Clinical Investigator Training 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 Pediatric Clinical Investigator Training Workshop will be held on Thursday, Feb. 28, 2019, from 8 a.m. to 5 p.m., in the Great Room (Building 31, Room 1503A) at the Food and Drug Administration, located at 10903 New Hampshire Ave., in Silver Spring, Md.

Among the topics to be covered is 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
  • Safety data collection

For More Information:

More information about this workshop, including registration, an agenda, and information about parking and directions, is available on this website.