Developing a Framework of Collaboration Between the EMA and Academia

Report from the workshop hosted by the EMA Healthcare Professionals’ Working Party (15 June 2016)

During its June 2016 meeting, the European Medicines Agency (EMA) Healthcare Professionals’ Working Party (HCPWP) hosted a workshop with the objective of promoting interaction between the EMA and academia. The aims of the workshop were to collectively review the status quo, present the different perspectives and expectations, and discuss the main pillars of the framework for collaboration.

There is already a longstanding collaboration between regulators and academia as recognised in the EMA’s Network Strategy to 2020. Academia provides the European medicines regulatory system with experts and is an important source of innovative medicines in the European Union. Consequently, opportunities for greater collaboration with academia need to be pursued in order to ensure that scientific and technical advances efficiently contribute to addressing the need for patient-focused innovation, as recommended by the European Council.

The workshop was conceived as an opportunity for brainstorming and input gathering from academic stakeholders. The exchange of information among organisers and participants and the lively, rich discussion were a confirmation of the willingness and commitment to successfully deliver a framework of collaboration.

The workshop agenda was built as to provide an overview of the current situation from the Agency’s perspective and some academic stakeholders’ perspectives, and elaborate on the opportunities and challenges lying ahead.  The full report from the workshop is available here.

To follow, we highlight a part of the report that reflects the participation of an ESMO representative. In particular, the afternoon session which provided a detailed overview of the concrete tools and actions which the EMA can leverage to successfully reach the goal of enhancing collaboration with academia.

The session was opened by Dr Rosa Giuliani (representing ESMO in the HCPWP), who presented the reflections and proposals of the HCPWP-Academia Topic Group (that she chairs with Sergio Bonini, EMA) on how to contribute to the enhancement of the collaboration between regulators and academia. The Group advocated for a more active involvement of academic healthcare professionals in regulatory activities via the enhancement of educational programmes, reciprocal participation in scientific events, and collaboration in regulatory science research projects.

The major outcomes of the discussion are summarised below:

  • Consensus on the opportunities of leveraging and enhancing existing activities in the field of education and training, potentially combined with research endeavours;
  • Call from academics to the regulators for supporting independent research (i.e. not industry driven), and proactively indicate priorities and a strategic research agenda in regulatory science, allowing timely and effective execution potentially underpinned by dedicated funding streams;
  • Consensus on the crucial importance of putting in place a communication strategy (in its tools and content) that will allow structured bidirectional exchanges.

The framework is set to be finalised and adopted by EMA Management Board by the end of 2016, with its initial implementation phase starting at the beginning of 2017.