Our key objective is to introduce a paradigm shift in pediatric drug research from a ‘top down’ to a ‘bottom up’ approach, starting with identification of current needs and shortcomings of pediatric drug knowledge. Our strategy should lead to a safe labeling of drugs for children in all age-groups, including critically ill children and children with co-morbidity. Results of our activities will be shared regularly by means of scientific publications and presentations at scientific meetings. Moreover,our most important valorization goal is to advice authorities on the minimal requirements for pediatric drug studies. This will incorporate validated statements to be included in new guidelines on the pediatric investigation plan (PIP).

The key objective is to reinvent the strategy for pediatric drug research from a top down approach derived from adult data, into a multidisciplinary methodology using a bottom up approach starting from pediatric specifics and opportunities, leading to a safe labeling of an efficient drug for children in all age-groups and all indications.

  • This academy driven program will identify the needs in our pediatric populations to be addressed and formulate solutions.
  • Identification of the opportunities of pediatric drug research, concentrating on the specifics in this pediatric population, including differences in pathogenesis (congenital, hereditary versus acquired.) and pathophysiology.
  • This multidisciplinary research will develop tools and techniques to innovate pediatric research to a bottom up approach, responding to the pediatric needs.
  • The most important social valorization is the advice to the authorities on what are the minimal requirements for pediatric studies, to reach optimal safe and effective therapy: this will incorporate validated statements to be included in new guidelines on the pediatric investigation plan implemented not only in Flanders but also abroad. There will be answers to respond on a new consultancy from the FAGG and EMA within 5 years.
  • Health Authorities: The results will be communicated on annual basis with our EMA representative, with FAGG, RIZIV and Zorgnet Vlaanderen.
  • Ethical committees: From the Ethical perspective, the need is very high for a comprehensive, clear and workable informed consent and assent. The outcome of WP7 will be communicated directly to the Chair of the Ethical Committee of the UGent, made public and implemented in guidelines.
  • Results will be discussed with representative groups such as representative of the patients and their families. The children’s rights commissioner who has advisory assignments onto the Flemish and Federal Parliament will transfer the new findings to the authorities.
  • The results will be shared with child Health professionals, medical doctors, pharmacists and pharmacologists by oral communications and scientific publications. Zorgnet Vlaanderen will be contacted for implementation in the pediatric care program.
  • The new opportunities will be discussed with experts of the pharmaceutical industry to tailor new pediatric studies more to the pediatric needs and to deliver the new tools.
  • The opportunity of the whole project is to increase knowledge- and education of pediatric pharmacologists, and to stimulate the academia to do pediatric research. It should result in the development of a multidisciplinary interuniversity center of excellence in Flanders as reference frame for all stakeholders.