Our mission

Dr. Edit Muhari-Stark is a pediatrician with regulatory and industry experience, passionate about providing children the high-quality, appropriately tested, safe and efficacious medicines they deserve. She has 4 years first-hand clinical experience with patients of all pediatric subgroups (premature infants to adolescents), in various subspecialties (general pediatrics, neonatology, neurology, cardiology) and settings (outpatient, inpatient, intensive care). This wide practical pediatric experience enabled her to also succeed as a pediatric medicines regulator later in her career, having a special eye for therapeutic needs, clinical trial feasibility, safety and efficacy. She worked as a pediatric medical assessor at the UK national medicines agency (MHRA) for 3 years. Her role included Paediatric Investigation Plan (PIP) assessments, presentations at EMA PDCO meetings, Article 45 and 46 submissions and pediatric safety reviews. To further strengthen her knowledge, she completed the Global Research in Paediatrics (GRiP) ‘MSc in Paediatric Medicines Development and Evaluation’ program awarded by the University of Rome Tor Vergata in 2016. The 2-year long MSc course included a fellowship at the US FDA Office of Clinical Pharmacology in Silver Spring, MD, which allowed her to gain insight into the pediatric regulatory procedures both sides of the Atlantic. Following her relocation to Research Triangle Park area in North Carolina, US, she joined the pharmaceutical industry side of pediatric drug development: initially as an idependent consultant to CROs and pharmaceutical companies (2017-2019), then as an employee of BioCryst Pharmeceuticals for 4 years (2019-2023). Edit also highly values pediatric research networks and serves as a board member of MCRN Hungary since 2014 and helps the important mission of Conect4Children (c4c) collaborative network.