Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Paediatric Drug Development from a Labeling Perspective - A detailed view on the European Summary of Product Characteristics with an exemplary comparison to the US Prescribing Information ***

Dr. Niklas Jänich (Abschlußjahr: 2016)

Summary
Language: English
Triggered by legislative initiatives in the European Union and the United States in the last decade, pharmaceutical companies had to increase their efforts to investigate medicinal products also in the paediatric population. Therefore today’s drug development processes are accompanied with the assessment of possibilities for a therapeutic use in the paediatric population.
This Master thesis aims to systematically investigate how the considerations related to paediatric development are translated into European prescribing information documents, i.e. Summary of Product Characteristics (SmPC) and what information is finally communicated to health care professionals via this medium. In order to achieve this, qualitative and quantitative criteria were established to associate information from SmPC documents to aspects relevant for the paediatric population. These criteria were then applied to a robust sample of SmPCs to yield over 600 datasets that were the basis for further analyses. The results of these analyses revealed a very clear picture on what information is communicated to health care professionals via the SmPCs. Information related to the paediatric population was gained for instance regarding the availability of information, different types of information or age ranges. Furthermore, an exemplary comparison to US prescribing information documents was performed.
Pages: 60, Annexes: Pages: 42