Event

Pediatric Formulation Development

Wednesday, June 25, 2025
8:30 a.m.-5:30 p.m.
University of Maryland, Baltimore, Pharmacy Hall, 20 North Pine Street, Baltimore, MD 21201 USA
M-CERSI
cersi@umd.edu

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland
Center of Excellence in Regulatory Science and Innovation (M-CERSI) in collaboration with IQ
Consortium - will host a two-day in-person workshop entitled “Pediatric Formulation
Development” on Wednesday, June 25 and Thursday, June 26, 2025.

Background:

Recent progress and advancements in drug delivery technologies and formulation sciences
have created new opportunities for developing better pediatric medicines. However, multiple
challenges and hurdles need to be overcome before these technologies can become fully
available to children.

By bringing together the pediatric community including pharmaceutical scientists and clinical
counterparts from diverse functions, the workshop is intended to shed light on the barriers to
and opportunities for patient-focused pediatric formulations. Advancing pediatric formulations
will require sharing and building on experiences from industry, academia and regulators. It is
hoped that the participants will better understand the principles, gaps, technical and process
challenges encountered during formulation and dosage product development as well as
considerations for regulatory assessments and ultimately policy development.

Objectives:

• Review progress in formulation development (since the previous workshop held in 2019)
•  Identify current gaps & propose actions
• Publish outcomes in workshop proceeding 

The workshop will combine lecture sessions covering the topics listed below, followed by small
group breakout interactive sessions where the challenges and mitigation options can be
discussed in more detail with the help of facilitators. The meeting format is designed to promote
the sharing of ideas and help to identify key issues and gaps to advance pediatric formulations.

Topics:

Funding Statement: 

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 to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $10,000 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.