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 hosted a two-day in-person workshop entitled “Shaping the Future of Pediatric Formulation Development.”
| Important Event Information | |
|---|---|
| Date: | June 18-19, 2019 |
| Time: | 8 a.m. - 5:30 p.m. |
| Location: | University of Maryland School of Pharmacy 20 N. Pine Street Baltimore, MD 21201 |
About the Event
Pediatric drug development continues to be an increasingly important topic for the pharmaceutical industry and global regulatory agencies. This two-day workshop will discuss formulation, analytical, and clinical elements of pediatric drug development, including regulatory and industrial perspectives.
Formulation elements to be discussed include:
- Strategies for co-packaging of drug products with devices (customized and off-the shelf).
- Safety and use of non-compendia excipients in pediatric patient population and application of database of pediatric excipients.
- Acceptability assessment (swallowability, mouthfeel and texture) of pediatric drug product and proposal for harmonized methodology for acceptability assessment.
Analytical elements to be covered include:
- Evaluation and validation requirements for dosing vehicles (compatibility, stability, and in-use).
- Specifications for multiparticulates: granules, mini-tablets, and pellets.
Clinical elements to be highlighted include:
- Pediatric PK, including unique patient population characteristics.
- Study designs, including methodology considerations.
- Biostudies to support formulation development.
Regulatory and industrial perspectives will include:
- Lessons learned during review of PIP/PSP by regulatory agencies and guidance for age-appropriate formulations.
- Future landscape and challenges, questions, and gaps encountered by industry in the development of age-appropriate formulations.
Ultimately, this workshop will enable:
- Sharing of current knowledge, practices, issues, and challenges in pediatric drug development.
- Exchanges of pediatric development approaches in the areas of age appropriate formulation, validation and specification requirements for pediatric drug product, clinical strategies to accelerate pediatric drug development, and regulatory and industry considerations.
- Identification of best practices to generate appropriate data during development of paediatric formulations for global use.
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.
If you have any additional questions about this workshop, please contact cersi@umd.edu.