Andrew Thomson (EMA), Ros Walley (UCB), Aurelie Gautier (Novartis) , Juan Abellan (GSK), and Robert Nelson (Johnson & Johnson).
In this PSI webinar, representatives from different pharmaceutical companies will present innovative approaches that address the challenges of developing pediatric medicines.
Children are considered a vulnerable population. Correspondingly, developing drugs for pediatrics is associated with a range of challenges including but not limited to ethical and methodological challenges. This includes the use of historical data, Bayesian methodology, and partial and full extrapolation approaches. The presentations are followed by a discussion of the topic from a clinical perspective and Q&A.