Shaping the Future of Pediatric Formulation Development
This two-day in-person workshop will cover pediatric formulations (mini tablets & excipients), patient-centricity, and future directions.
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), the IQ Pediatric Consortium, and European Paediatric Formulation Initiative (EuPFi) will host a two-day in-person workshop: Shaping the Future of Pediatric Formulation Development.
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, regulators 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 patients/caregivers, 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.
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.
Good to know
Highlights
- 1 day 9 hours
- In person
- Paid parking
- Doors at 7:15 AM
Refund Policy
Location
University of Maryland School of Pharmacy
20 North Pine Street
Baltimore, MD 21201
How do you want to get there?
Agenda
Patient-Centricity
Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste-masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing regimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerable population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics.
Formulation and Analytical Aspects of a Pediatric Dosage Form: Mini Tablets
This session will focus on key aspects of developing mini tablets as a dosage form for pediatrics. This session will provide a forum to discuss acceptability of mini tablets across pediatric age groups, inconsistencies in nomenclature, manufacturing and packaging challenges and limitations, and strategies for identifying appropriate food vehicles.
Formulation and Analytical Aspects of a Pediatric Dosage Form: Excipients
This session features presentations on the assessment of excipients for pediatric formulations, including tools such as the IID and ELSA, delivered by FDA experts. Industry perspectives are provided through talks on challenges and considerations in selecting excipients for pediatric products, including the use of the PERA tool. Additional insights focus on excipient needs for special populations—such as neonates. The program concludes with a breakout session on the PERA tool and a forward looking panel discussion on future needs, research priorities, and regulatory challenges in pediatric excipient development.