Pediatric Clinical Investigator Training Workshop
Thursday, February 28, 2019
8:00 a.m.-5:00 p.m.
Great Room (Bldg 31), Room 1503A, Food and Drug Administration, 10903 New Hampshire Avenue
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