EMA to Collaborate More Closely with Academia

On April 3, 2017, the European Medicines Agency (EMA) announced that it has developed a framework to further develop interactions with the academic community in the context of the European medicines regulatory network. The framework and three-year action plan were adopted by EMA’s management board during its March 2017 meeting, the agency said in a press release.

“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,” Guido Rasi, EMA’s executive director, said in a statement. “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 frameworks overall objectives include:

• Raising awareness of the mandate and work of the European medicines regulatory network to increase academia’s trust in and engagement with the regulatory system

• fostering the translation of academic research into novel methodologies and medicines which meet regulatory standards and address needs of public and animal health

• ensuring that the best scientific expertise and academic research are available on time to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes

• working with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, for example, the use of novel endpoints or novel methodologies.

The framework builds on EMA’s experience in interacting with stakeholder associations representing patients and consumers, healthcare professionals, and the pharmaceutical industry. 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 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.

Source: EMA