U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?
  1. Drugs

Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?

Date and Location

Date: May 16, 2019

Time: 8:00 am – 4:15 pm

Location: The meeting will be held at:

Kirschstein Auditorium, Natcher Conference Center, NIH Main Campus
Bethesda, MD

NIH Visitor Information: https://www.nih.gov/about-nih/visitor-information

Natcher Conference Center Information: https://www.genome.gov/11007522/natcher-conference-center-information/

Background:

The Food and Drug Administration (FDA or the Agency) is announcing a public workshop to discuss the present state of understanding of pediatric ontogeny as it pertains to pediatric drug development. The workshop aims to address the incomplete information available on the ontogeny of several relevant physiologic systems in pediatric patients as it relates to predicting drug dosing and response in this population. These considerations are of most importance to the youngest pediatric patients, where model-informed drug development has the most potential to expedite pediatric drug development using techniques such as physiologically-based pharmacokinetics (PBPK).

Meeting Information

Registration

For registration or the agenda, please visit the MCERSI website:   https://www.pharmacy.umaryland.edu/centers/cersievents/PedsOntogeny/

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at aanonsen@umd.edu at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at interpreting.services@oc.fda.gov.

Questions
If you have questions about registering for the meeting, contact Gilbert Burckart, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-2065, or email gilbert.burckart@fda.hhs.gov or Ann Anonsen at aanonsen@umd.edu