The European Medicines Agency (EMA) is committed to maintaining a strong working relationship with European academics and researchers. Collaboration between the Agency and academia is necessary for the Agency to be prepared for future challenges and opportunities offered by advances in science and technology.
Framework for collaboration
The EMA Management Board adopted a framework for collaboration between EMA and academia in March 2017. This aims to:
- raise awareness of EMA's role within the European medicines regulatory network;
- promote and further develop regulatory support for translating academic research into novel methodologies and medicines;
- ensure that the best scientific expertise and academic research is available to inform regulatory decision-making;
- collaborate on areas of research on regulatory science, such as novel approaches, endpoints and methodologies.
The supporting action plan describes activities that EMA will undertake to implement the framework, including:
- raising awareness on the support the Agency can offer;
- seeking to better understand academics' and researchers' support needs;
- providing education and training for these stakeholders.
EMA published the framework and the action plan in April 2017:
- Framework for collaboration between EMA and academia
- Annex I - Framework for collaboration between EMA and academia: action plan
Involvement of academia in EMA activities
Academics and researchers participate in the work of the Agency in several ways, including:
- as members and experts of its scientific committees and working parties;
- in the preparation of scientific guidelines;
- as seconded national experts;
- as visiting experts ;
- taking part in the Agency's conferences and workshops.
Stakeholder engagement report 2017
EMA publishes an annual report on its interactions with patients, consumers and healthcare professionals, academics and their organisations, incorporating both quantitative and qualitative data.
For previous reports, see Key documents for healthcare professionals.
Background to the framework
EMA held a survey with academics and researchers in early 2016 to better understand existing interactions between European Union regulatory bodies and these stakeholders.
The survey report identified a need to raise awareness about regulators' roles and activities and strengthening the support they offer to academia:
During its June 2016 meeting, the Healthcare Professionals' Working Party (HCPWP) held a workshop dedicated to discussing the pillars of the framework. It identified opportunities for leveraging and enhancing existing education and training activities and strengthening communication.
Representatives of academia called for regulators to support independent research and proactively indicate priorities and a strategic research agenda in regulatory science.
For more information, see:
- HCPWP workshop with academia (15/6/2016)
- Workshop report: Developing a framework of collaboration between EMA and academia
The framework of collaboration with academia is in line with EMA's overarching framework for stakeholder relations management: