Children frequently respond differently to therapies compared to adults. Differences
also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety.
Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response,growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population-specific factors (e.g., more frequent use of offlabel/unlicensed drugs).
In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development.
This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which are described in this article.
These considerations include practical points to consider for the development of the
paediatric section of the risk management plan (RMP), safety in paediatric protocol
development, safety data collection and analysis.