Exon Consultancy and Utrecht University executed the project, with support of additional public and private partners providing data and expertise. A scientific analysis of topics in a number of key areas in the regulatory system was performed, including: pharmacovigilance & post-authorisation safety studies studies, the conditional marketing authorisation pathway, the decentralised & mutual recognition procedure and paediatric investigation plans. The results of this project were presented to key stakeholders in an interactive workshop in Brussels, organized by TOPRA. The workshop resulted in an important contribution to the debate on improving the regulatory system for the benefit of all stakeholders.
