Pharmacology and Drug Development delves into the translational pathway from preclinical pharmacology to paediatric therapeutic trials, regulatory considerations and clinical prescribing best practices for children. This session is crafted for paediatric pharmacologists, clinical trialists, regulatory specialists, paediatricians and pharmacists involved in drug development or formulary decisions. Presentations will cover age-appropriate pharmacokinetics and pharmacodynamics, dose-finding strategies for neonates and children, adaptive trial designs, and methods to predict and monitor adverse drug reactions. Special attention will be paid to off-label prescribing practices and how to strengthen evidence through pragmatic trials, registry-based studies and collaborative networks that accelerate data gathering while protecting vulnerable populations.

Speakers of Pediatric Drug Development Conference will unpack modern trial methodologies—model-informed drug development, physiologically-based pharmacokinetic modelling and Bayesian dose-escalation—to show how they can reduce sample size requirements and improve dose selection for paediatric cohorts. Regulatory panels will guide attendees through international pediatric investigation plans, ethical frameworks, assent/consent challenges and post-marketing surveillance obligations. Clinical sessions will focus on stewardship: strategies to safely transition adult formulations to child-appropriate dosing, compounding standards, and approaches to minimise medication errors in ambulatory and inpatient settings.

Practical modules include building hospital formularies with a paediatric lens, instituting robust medication reconciliation processes, and using clinical decision support to flag weight-based dose errors. Case studies will highlight successful public–private collaborations that expedited vaccine or therapeutic approvals for children during public-health emergencies, and workshops will provide templates for investigator-initiated trials, grant applications and industry partnerships that protect scientific integrity while achieving feasibility.