Challenges and Strategies to Facilitate Formulation Development of Pediatric Drug Products
IQ is jointly organizing this workshop with University of Maryland Center for Excellence in Regulatory Science Innovation. The overall aim of the workshop, scheduled for June 8-9, 2016 at the College Park Marriott Hotel and Conference Center, is to define risk-based strategies to support the development of pediatric age-appropriate drug products. Participants will review current status and gaps in strategic areas, as well as discuss regulatory convergence approaches to meet the requirements of all stakeholders (e.g., patients, regulators, practitioners, and industry). Workshop objectives include:
- To share current practices in developing pediatric drug products globally.
- To discuss development approaches for age-appropriate formulation and safety qualification of excipients in pediatric formulations.
- To identify harmonized strategies to generate appropriate data during pediatric formulation development.
- To provide a perspective on the development of pediatric medicines for a possible ICH E11 guideline on pediatric drug development.
Complete information is available on the event website: http://pharmacy.umaryland.edu/centers/cersievents/pedsformulation/.