Pediatric Regulatory Strategies and Trends in the EU and US

Pediatric regulatory requirements are now established aspects of EMA and FDA frameworks. These requirements have sparked, since their inception, enthusiasm and criticism on how they enable pediatric drug development, particularly in areas of unmet medical needs. From mandating clinical research in children to creating new opportunities for dialogue, this session will bring together developers, former and current regulators to discuss where do we go from here and what challenges are still to be tackled. Pediatric development, particularly in rare diseases or even rare cancers, have shifted paradigms and created new regulatory opportunities, such as the Rare Pediatric Designation program and Priority Review Voucher or mechanism-driven pediatric requirements. At the same time, pediatric frameworks allowed different stakeholders to more closely work together to accelerate pediatric research and development, and raise awareness on advocacy. The session will present a status update on these frameworks, especially on how to align regulatory and clinical requirements, and what is still to be done to ensure these frameworks remain fit for the pediatric R&D of the modern age.