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.
The Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled “Pediatric Dose Selection” on October 22nd and 23rd, 2020 to discuss the present state of dose selection and how it pertains to paediatric drug development.
The workshop aims to review the current methods used to determine the paediatric dose, address ways to overcome dose selection challenges in paediatrics and evaluate future approaches. The workshop is addressed to clinicians, drug developers, and regulators.
The date and timeline of the workshop are:
- Day 1: Thursday, October 22, 2020 10:00 AM to 3:00 PM ET
- Day 2: Friday, October 23, 2020 10:00 AM to 12:30 PM ET
Information about the event, including details about registration and an agenda, is available at the following link: https://www.pharmacy.umaryland.edu/centers/cersievents/pedsdoseselection/
It is necessary to pre-register and you will receive the link to access the live webinar several weeks prior to the meeting logging in with the username and password which you create when you register.