I am a Neonatologist and Professor of Pediatrics at Stellenbosch University, Cape Town, with an interest in neonatal infectious diseases and the pharmacological evaluation of anti-infective medicines in preterm and term neonates. I am actively involved in the NIH-funded International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network and am participating in various neonatal and pregnancy antiretroviral pharmacokinetic (PK) studies. I am also co-principal investigator of a series of PETITE studies, evaluating the PK and safety of solid antiretroviral formulations in neonates. The PETITE-DTG study is one of only 2 studies evaluating the PK of dolutegravir (DTG) in term neonates and includes the assessment of a novel DTG oral dispersible film. I have been a member of the WHO Pediatric AIDS Working Group and the Clinical Pharmacology Working Group within PENTA since 2021.

Tjitske van der Zanden is the technical director of the Dutch Paediatric Pharmacotherapy Expertise Network, that publishes the Dutch Paediatric Formulary (www.kinderformularium.nl ). Originally trained as a nurse and a clinical research coordinator, she worked on several paediatric clinical studies at the ErasmusMC-Sophia Childrens Hospital in Rotterdam, before she joined the Dutch Paediatric Formulary as a projectmanager from the very start in 2005. As a projectmanager and later on the technical director Tjitske is responsible for the technical development and maintenance as well as the contents (dosing information) of the Dutch Paediatric Formulary. In 2025 she completed her PhD on ‘Risk mitigation strategies for off-label drug use in children” at the Radboud UMC in Nijmegen. This dissertation shows that in children, dependent on age group 30-70 % all medicines are still used off-label and that a proper assessment of risks and benefits in pediatrics is severely hampered by the lack of available high-quality evidence. Because off-label use in children is still a necessary evil, this dissertation describes a number of innovative strategies to improve the quality of decision-making on and the provision of information about off-label use in children and thus to reduce the risks of off-label use.

Ronaldo Morales Junior is a Clinical Pharmacist specializing in pediatric care and precision dosing. He holds a Ph.D. in Pharmaceutical Sciences from the University of São Paulo (Brazil) and currently works as a Postdoctoral Researcher in Clinical Pharmacology at Cincinnati Children's. His research focuses on the pharmacokinetics and pharmacodynamics of antimicrobial agents, with a particular emphasis on critically ill children, post-transplant patients, and neonates. He investigates key factors affecting drug disposition to optimize antibiotic dosing strategies.