Efficient and adequate safety assessment remains one of the main challenges in the drug discovery, development and submission process. Recent advances have shown that sharing of public & private pre-clinical data is achievable. In parallel, the electronic CDISC-SEND format has been chosen for file submission to the FDA.

A strengthened capacity in Europe to monitor the effectiveness of the yearly seasonal influenza vaccines across age, risk groups and vaccines is needed. National public health bodies have a role in assessing national vaccination programmes, and vaccine manufacturers are accountable for the quality and integrity of vaccine product-specific data presented to regulatory authorities.

The central challenge to be addressed is to establish and validate non-invasive markers for classifying and evaluating subjects with NAFLD, and in particular to identify amongst those with NAFLD, individuals who have Nonalcoholic steatohepatitis (NASH). Identifying and validating these biomarkers will be crucial in furthering an understanding of the factors that drive the heterogeneity of NAFLD and in enabling accurate diagnosis of those with NASH.

Autoimmune diseases affect approximately 5% of the population of Europe, with two-thirds of the patients being female.

Reproducibility and relevance of research findings represent the pillars of the scientific method. For drug development, robust data and scientific rigor are key drivers for decision making, determining patent strength, time-to-market and consequently availability of new treatments to patients. Substantial evidence has accumulated that robustness, rigor and validity of research data can be problematic.

The activity aims at developing and validating radically new ICT based concepts and approaches for empowering and motivating people in need of guidance and care due to age related conditions, in cooperation with their carers where relevant, and to help them improve and maintain their independence, functional capacity, health status as well as preserving their physical, cognitive, mental and social well-being.

In biomedical, pharmaceutical and toxicology research, the safety and efficacy of biomedical products are ultimately tested on humans via clinical trials after prior laboratory testing in vitro and/or in vivo on animal models. The complete development chain of a new biomedical product and its introduction to the market is very long and expensive. Alternative methodologies to reduce the animal and human testing are needed in order to answer both the ethical issues and the imperfection of predictions issued from laboratory and animals when applied to humans.