IQ Collaborates with University of Maryland Center for Excellence in Regulatory Science

June 17, 2019 - June 19, 2019

Workshop

Location: Baltimore, Maryland

Venue: University of Maryland School of Pharmacy

Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow, a two-day workshop sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) in collaboration with IQ Consortium.

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.