The need to develop improved medicines for pediatric populations is driving a greater requirement to include children in the drug development process. The focus on developing pediatric products and the number of pediatric clinical trials is increasing in response to new regulation, increased funding and scientific advances in areas of special benefit for children. This emerging research environment creates a unique set of challenges for today’s drug development companies.
Quotient Sciences and PPD provide an innovative solution to solve these challenges that offers end-to-end support for all stages of pediatric drug development from chemistry and manufacturing through all clinical trial phases, and commercial manufacturing. Our partnership helps industry accelerate the development of medicines for pediatric populations.
In this webinar, we will explore:
- Product considerations when designing acceptable, palatable pediatric products including formulation, clinical assessment and manufacturing;
- Clinical and operational considerations when executing and designing clinical pharmaceutical trials for pediatric patient populations;
- Regulatory considerations for pediatric drug development including US and EMEA incentives, guidance and requirements.