Mark your calendars for "Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?", a one-day conference sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Scheduled for Thursday, May 16, 2019, "Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?" 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 in this population.

Important Event Information
Date: Thursday, May 16, 2019
Time: 8 a.m. - 4:15 p.m.
Location: National Institutes of Health
Natcher Conference Center, Kirschstein Auditorium
9000 Rockville Pike
Bethesda, MD 20892

About the Event:

Modeling and simulation can reduce the numbers of pediatric patients to predict drug dose and effect, but such predictions rely on solid information on the ontogeny of the systems that interact with the new drug.

The objectives of this workshop are to:

  1. Review the present state of knowledge of the ontogeny of systems critical to drug dosing and effect in pediatric patients.
  2. Discuss whether our knowledge of ontogeny of specific systems is adequate at the present time to make pediatric dosing and effect predictions through modeling and simulation.
  3. Identify pathways forward for acquiring the additional information needed for incorporating ontogeny into modeling and simulation predictions for pediatric new drug development.

Webinar Instructions:

To view the webinar, please visit:

On the day of the event, visit the above NIH webinar page and launch the link to join the meeting. The meeting times are in the Eastern Time Zone, Washington, D.C. local.

Select "Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development" Thursday, May 16, 2019 link.

Special Accommodations:

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at 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

For More Information:

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