REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. The heart of our framework is the development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by regulation by the best-fitting methods. The decision tree will explicate the product’s specific regulatory challenges and the priorities of both missing data and missing methods to match these challenges. It will thus allow planning a cost-and time efficient strategy both for necessary measurements and for the advancement of methods. Our approach is aligned with the industrial R&D practice of stage gating. We will demonstrate the relevance of the framework for the most pressing regulatory challenges, which are: borderline products, nanosimilars, and products combining several functionalities. In order to do so, we will identify the regulatory challenges with Regulation Authorities from Europe and abroad, and design methods for tiered decision tree, guided by the latest scientific knowledge. We will study/predict physiological distribution of nanomedicines and biomaterials, as well as develop and validate new analytical or experimental methods and assays requested by the regulators. These latter development will be performed in a quality management system, ensuring the possible standardisation of our assays. REFINE will gather a wide community of stakeholders in regulation, industry, science, technology development, patients, and end-users, into a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.

"The project went almost 100% as planned. Minor challenges occurred, not worth mentioning. The project ""The Ego was about open the discussion up to the genera public. Along side the intense group work with the 4 groups from Iceland, Denmark, Sweden and England (64 individuals), we were launching the LungA lab. The LungA Lab is an open philosophical and educational platform where we invite the people of Seyðisfjörður, it’s guests and the world to participate in a ambitious program with lectures, movie screenings and discussion forums during the LungA and Erasmus+ 2017 youth exchange program. We got philosophers and artists to give talks about the topic, from their personal and professional perspectives, we facilitated open discussions and performances in the hope of generating a broader conversation and a deeper impact on a more wholistic level.In the ""LungA Lab, the ego” 2017 project, we discussed the different layers of the human ego, including the alter ego and other possible variations there may be. We did research Freuds theories as well as Kirkegård, Plato and other philosophers. The outcome isn't whats important but the journey, the conversation and the possible self realizations along the way.As individual human beings, we are only powerful enough to change the way we think by installing new perspectives in to our hard drive. New perspectives can be created through discussion and confrontation of other points of view.Philosophy has worked with the division of the self, the ego, the consciousness, for as long as philosophy has existed, but how is it relevant today? We live in a world ruled by alteregos, illusions, and make-believe, where the most important personality trade is to be able to create a profile so strong that people wont ever see that you are actually human, with flaws and all. An illusion that contaminates our ability to actually balance between the different layers of our selves. Our becoming Prime Minester Katrín Jakobsdóttir gave a great lecture about the ego in politics. Goddur, Þórunn Eymundar and Samantha Shay took the artistic and philosophic point of view on the topic. Participants took part in art workshops, leaded by well known and lesser known artists. Everyone were offered to chose from eight different workshops in advance. The LungA Lab were run in conjunction with the workshops so the discussion about the Ego was the theme from day one to the end. Artistic program open to participants and general public was also run along with the workshops."

The South-East coast is a unique peri-urban settlement site for asylum seekers, due to processing centres in nearby Kent and Croydon, Hastings' longstanding use as a dispersal centre, and growing refugee communities. Few studies exist of i) how the mental health experiences of young people during critical times of transition are addressed by mental health service provision; ii) ways mental illness aetiologies are informed by demographic and political transformations globally, and in the South-East coast as a specific locality iii) the relevance of young refugees' experiences for mental health policy and public debate. This study will develop an interdisciplinary approach to mental illness and related treatment within historical processes of demographic, regional and individual transition (Khan 2017). Methods could include in-depth interviews and focus groups with clinical and community service providers and young people, small-scale ethnographic insights in user settings, and to coproduce critical bridgework during information exchange sessions between young people, carers, and service providers. Findings will be shared with relevant stakeholders to inform public health policy for marginalised groups (Zeeman et al 2017), specifically, adolescents affected by war and migration on the South-East coast.