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Archive duration: 1 hour 37 minutes

Series Overview
Knowledge of new medicines for children and clinical research has increased over the past decades. A revolution has taken place in pediatric oncology, where new dosing and new combinations of anticancer drugs developed for adult cancer have made the diagnosis of child cancer no longer an automatic death sentence.

DIA is presenting a Seven-Part webinar series on Pediatric Drug Development, which will start with an overview of the challenges and historical background of pediatric drug development, then proceed to specific discussion of US and EU pediatric legislation, and, in four additional pivotal webinars, discuss technical specificities of dosing in children, particular requirements in pediatric clinical trials, the development of pediatric formulations, and the need and challenges of juvenile animal studies.

Part III: Regulatory Framework EU Overview
After many years of deliberation, an EU pediatric regulation came into force in 2007 that combines voluntary and mandatory aspects, with an emphasis on mandatory requirements. More ambitious than the US laws, this legislation emphasizes the need for the inclusion of children at an early stage of the drug development process. There is also increasing cooperation between the regulatory authorities in the US, EU and Japan with regard to the use of medicines in children.

The EU pediatric regulation has introduced clear requirements for drug approval and label claims that demand more than just scattered scientific evidence from drug use in children. The theory is that safety and efficacy of all drugs need to be proven based on a well-thought development plan adapted to the specific therapeutic needs of children. As the EU regulation requires a pediatric discussion with the EU regulatory authority after the end of phase I, at present pharmaceutical industry discusses pediatric development often with the EU regulatory authorities first and with the FDA much later.

This webinar will focus on the operational requirements and challenges of the EU pediatric legislation and its consequences for industry, authorities, the clinical world, and the pediatric patients through representations by key opinion leaders.

Other Webinars in this Series:

Part 1:  Overall Challenge: The Vision of Better Medicines for Children
Part 2:  Regulatory Framework
Part 4:  Dosing in Children
Part 5:  Technical Development: Pediatric Formulations
Part 6:  Preclinical Toxicology & Safety
Part 7: Operational Challenges of Pediatric Clinical Trials