Dr. Kerpel-Fronius was born in Budapest, Hungary in 1940. He obtained medical diploma and board certificates in Clinical Laboratory Sciences and Clinical Pharmacology. He received PhD degree and DSc titles from the Hungarian Academy of Sciences. First, he worked in neurobiology at the Semmelweis University, later he led a clinical research group at the Hungarian National Institute of Oncology. Between 1989-2001 he worked in the international pharmaceutical industry. In 2001 he became Professor of Clinical Pharmacology at the Semmelweis University. In 2016 he was appointed Honorary Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians. He is member of the IFAPP Ethics Working Group.

Neonatologist with a special interest in early phase drug development and improving the availability of high quality medicines to children and babies. Has studied 20 medicines in neonates and pregnant women including antibiotics, excipients, treatments for in utero growth restriction, inotropes, postnatal steroids and surfactant. Current work is focused on developing research infrastructure for pediatric medicines research in Europe and beyond.

Prior to joining SECMOH in 1999, he worked as an urologist. He is an author of more 70 articles on various topics related to clinical trials in Ukraine, including: inspection, expert evaluation of CT materials, ethical and regulatory issues. He was involved in the conduct of more than 500 inspections (clinical audits) of clinical trials in Ukraine (incl. those performed by inspectors from FDA, EMA and PMDA). In 2014-2016 he completed the Vilnius University Research Ethics Program and the Clarkson University Bioethics Program. In 2014, 2016, 2017, 2018 he participated in EU GCP Inspectors Working Group Workshops. In 2015 he completed “On-line EU GCP Inspectors Basic Training Course”.

Aneta Sitarska-Haber is associated with the clinical trials industry since 1998. She has medical background, graduated at the Medical University of Warsaw. Since 2005, she has been working at PPD Poland (part of Thermo Fisher Scientific), a global CRO company, currently as Associate Director of Clinical Research. She is responsible for supervising, coaching and training the clinical team (CRAs, remote monitors, CTC) developing the partnerships with site research networks and liaison with Patient Advocacy Groups by promoting patient centricity approach. She is a Vice-president of the GCPpl Association. She cooperates with the Medical Research Agency and is a member of the Polish Platform of EUPATI (European Patients' Academy).