Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators.

ABSTRACT:

Background

The European Medicines Agency (EMA) interacts with many different stakeholders involved in the development of drugs, including academic researchers. In recent years, EMA has collaborated more closely with academia, inter alia by taking part in external research projects such as those set up under the Horizon 2020 program in general and the Innovative Medicines Initiative in particular. The aim of this study was to evaluate the perceived added value of EMA's involvement in these projects, both from the perspective of the Agency's participating Scientific Officers and of the coordinators of the consortia that undertook them.

Methods

Semi-structured interviews were conducted with the coordinators of 21 ongoing or recently finalized projects in which EMA has pa

SUBMITTER: Saesen R 

PROVIDER: S-EPMC10267977 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature