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) and the IQ Consortium will host a two-day in-person workshop entitled “Pediatric Formulation Development,” June 25-26, 2025.
| Important Event Information | |
|---|---|
| Date: | June 25-26, 2025 |
| Time: | 8 a.m. - 5:30 p.m. |
| Location: | University of Maryland School of Pharmacy 20 N. Pine Street Baltimore, MD 21201 |
| Registration: | Online Registration Available Here Registration will close at 5:30 p.m. on Monday, June 17. |
| Poster Session: | Poster session is scheduled for June 18, 2019. Submit your poster title here. |
| Pre-Meeting Readings and Information | Materials available for download here. |
About the Event:
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, this 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 and propose actions
- Publish outcomes in workshop proceedings
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 workshop format is designed to promote the sharing of ideas and to help identify key issues and gaps to advance pediatric formulations.
| Main Topic | Subtopic (tentative) |
|---|---|
| Formulation and Analytical |
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| Patient-centricity |
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| Global Access |
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| Future |
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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 and 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.
Special Accommodations:
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.
For More Information:
More information about this workshop, including registration, an agenda, and information about how to submit your poster title and parking and directions, is available on this website.
If you have any additional questions about this workshop, please contact cersi@umd.edu.