M-CERSI "Pediatric Dose Selection" Conference
Thursday, October 22, 2020
10:00 a.m.-2:00 p.m.
"Pediatric Dose Selection" aimed to address the incomplete information currently available on determining dose selection in the pediatric population. This was a two-day workshop; it took place on Thursday, October 22, 2020 and Friday, October 23, 2020.
This virtual event will took place from 10:00 a.m. - 3:00 p.m. on Thursday, and 10:00 a.m. - 12:35 p.m. on Friday.
About the Event:
Dose selection for new drug products remains a critical part of pediatric drug development. A variety of techniques have been used to predict the pediatric dose, but the prediction is generally based on no or incomplete pharmacokinetic data. This workshop is intended for clinicians, drug developers, and regulators.
The objectives of this workshop are to:
1. To review the current methods of pediatric dose selection;
2. To discuss how to address the gaps in pediatric dose selection that occur because of the inability to perform studies in pediatric patients;
3. To evaluate future approaches to pediatric dose selection in all pediatric patient populations.
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.