Pediatric Drug Development

Pediatric drug development requires age-specific evidence with growing regulatory mandates. The session covers BPCA (Best Pharmaceuticals for Children Act) and PREA (Pediatric Research Equity Act), paediatric formulation development, neonatal drug trials and ethics, paediatric pharmacokinetics including drug clearance ontogeny, paediatric oncology approvals (RACE for Children Act 2020), and adolescent transitions. Discussion addresses Pediatric Investigation Plans (PIPs) in EU, the rare-pediatric-disease priority review voucher programme, the comparison of US and EU paediatric frameworks, formulary access in paediatric care, and the integration of paediatric expertise in trial design.