Abstract
Recent and ongoing regulatory agency activities have required the understanding of the safety and efficacy of novel medicines specifically in the pediatric population. Developing drugs for pediatric indications present many scientific challenges, particularly in the preclinical stage where there are very few publications describing a successful preclinical development package and/or interpretation of data from preclinical studies. It is imperative that those involved in preclinical evaluation of drugs design and interpret studies using the best scientific approach to ensure that those children dosed with the drugs are treated safely, but also that the pediatric population is not denied access to effective treatment due to an inappropriately negative interpretation of data. This Annual General Meeting brings together leading experts in academia, industry, politics, and regulatory authorities to discuss the scientific and political issues associated with the need to provide preclinical understanding of the safety of drugs that will be administered to children. In particular, previous experience of juvenile toxicology studies that have supported dosing of drugs to children will be discussed in detail.