Lessons learned from Escher and CBG-MEB Regulatory Science Projects

The aim of this project is to explore ways of consolidating the knowledge, data and experience gathered in previous Escher research. The combined effort of previous Escher research has resulted in a greater understanding of the regulatory process. In the context of Escher research, a wealth of data on the regulatory process has been collected, validated and interpreted through specific research questions by various researchers. Moreover, many of these data sources were not used in research before. Therefore, it is essential to ensure that this data, knowledge and experience is captured and maintained which this project has developed a proposal for doing so.

The project does this in the form of creating a data repository of key medicine development and regulatory review characteristics; and by establishing a network of experts in this field. In addition, this project will single out one suitable overarching question – such as the role of single pivotal trials as key evidence for marketing approval applications – around which it tests the feasibility of a lasting knowledge network. Experts from regulatory authorities and private partners are consulted to identify the most promising avenues of knowledge consolidation. It is through these activities that the project hopes to facilitate regulatory science.