Who is this event intended for?: This course is aimed at biostatisticians with no or some paediatric drug development experience

Overview: This is a short course where we will give you an introduction to the pediatrics drug development. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges to conducting pediatric research and focus on the ways to overcome these challenges from a statistical perspective. In particular, the extrapolation concept will be presented through reviews and examples. We will list and give examples of the use of non-standard statistical methods that can and/or has been used in the pediatric development. These will include the use of adaptive designs, platform trials and Bayesian approaches.