As a science-driven organization, the EMA has developed a framework to formalize, structure and further develop interactions with the academic community in the context of the European medicines regulatory network.
The framework and an action plan for the next three-years were adopted by EMA’s Management Board at its March 2017 meeting.
“Academia play an important role in helping the EU medicines regulatory network keep abreast of the opportunities and challenges brought by science, be it in the context of the development, assessment or safety monitoring of medicines, said the EMA’s Executive Director Guido Rasi. “The framework will allow us to integrate cutting-edge scientific knowledge more tightly into our activities. It will also help academic start-ups benefit from advice from the EU regulatory network to translate their discoveries into patient-focused medicines.”
The framework’s overall objectives are:
The framework builds on EMA’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals and the pharmaceutical industry, which is based on the fundamental principles of transparency, independence and integrity, accountability, and broad representation.
Along with the framework, EMA has developed an action plan which includes, among other activities, initiatives for mutual education and training, staff exchange programs to promote mutual learning, a strategic research agenda for regulatory science and the creation of an EMA entry point for academia to receive information on available support within the EU Regulatory Network.
EMA also published today a new web page for academia providing links to content that is likely to be of interest, and a section describing the way EMA interacts with academia, with more detail on the collaboration framework and action plan and useful resources for academics.