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This document presents the contributions discussed at the second institutional workshop on Artificial Intelligence (AI), organized by the Joint Research Centre (JRC) of the European Commission. This workshop was held on 05th July 2019 at the premises of the JRC in Ispra (Italy), with video-conference to all JRC's sites. The workshop aimed to gather JRC specialists on AI and Big Data and share their experience, identify opportunities for meeting EC demands on AI, and explore synergies among the different JRC's working groups on AI. In comparison with the first event, according to the JRC Director General Vladimír Šuchav, the activities and results presented in this second workshop demonstrated a significant development of AI research and applications by JRC in different policy areas. He suggested to think about replicating the event at the premises of diverse policy DGs in order to present and discuss the clear opportunities created by JRC activities. After the opening speech by the JRC Director General Vladimír Šuchav, the research and innovation presentation were anticipated by two presentations by Alessandro Annoni and Stefano Nativi. The first presentation dealt with the results of one year of AI@JRC and six months of fully operational AI&BD community of practice1. The second presentation reported the results of the AI competences survey at JRC. The research and innovation contributions consisted in flash presentations (5 minutes) covering a wide range of areas. This report is structured according to the diverse domain areas addressed by the presenters. While the first part of the workshop was mainly informative, in the second part we collectively discussed about how to move on and evolve the AI&BD community of practice., JRC.B.6-Digital Economy

The application of nanotechnology in healthcare is widely accepted as a potential driver of biomedical innovation. By exploiting the unique physical and physicochemical interactions at the molecular level nanotechnology based products (also known as nanomedicines) can monitor, repair and control biological systems in order to address diseases for which currently no or only insufficient diagnostic and therapeutic tools are available. Nanotechnology will also play an enabling role in the implementation of personalised medicine as it provides tools for a better prediction and early diagnosis, the design of personalised treatment as well as a close monitoring of the therapeutic success. However, the opportunities of nanotechnologies in the health sector are coming along with challenges in the regulation of this emerging product class. Sufficient knowledge on their quality, safety and efficacy must be gained and standardised methods must be made available to support the regulatory decision making and allow a smooth translation towards clinical applications. The current survey was performed within the "nanomedicine" working group of the International Pharmaceutical Regulators Forum (IPRF) with the aim to get a general overview on the status and regulatory needs of nanomedicines. The survey demonstrated strong regional differences in the regulation of nanomedicines and demonstrated that in the last years, the European authorities have received fewer applications of nanotechnology based pharmaceuticals as e.g. the USA. However, a future increase of market applications must be anticipated in Europe as other regions which have a better ecosystem for the marketing of nanomedicines are already facing challenges in the regulation of nanotech products. These expectations are supported by the fact that the last EC's framework programmes have invested hundreds of millions of Euro into nanomedicine development in order to make these promising products available to the patient. An intensive exchange of experience in the regulation of nanodrugs between regulatory bodies is now necessary to ensure harmonised regulation of products internationally. The respondents of the survey confirmed the need for the harmonisation of information requirements on nanospecific properties. A number of critical physicochemical properties have already been proposed in the scientific literature and their relevance for regulatory decisions was verified within the survey. Some regulatory agencies also indicated the need for additional (eco)toxicological testing triggered by the nanospecific property of the product. Finally, there was consensus among the regulatory agencies for a need of an independent nanocharacterisation testing facility that can support regulators in the evaluation of sophisticated material and the performance of new test methods before entering into clinical applications., JRC.F.2-Consumer Products Safety