The Health Directorate of the European Commission's DG Research and Innovation recently stated that Personalized Medicine is one of the most innovative areas in the future of health research with a high potential for patients, citizens and the economy. However, today the full potential can not be developed due to fragmented activities, insufficient communication and lack of generic solutions in the different areas of Personalized Medicine.The implementation of Personalized Medicine is, therefore, a major challenge in Europe and beyond. It calls for appropriate governance strategies at the European and global level as it challenges the way in which healthcare systems worldwide are set up. Thus, the EC itself, EuroBioForum, the European Health Forum Gastein (EHFG) and others have organized conferences to tackle these challenges. Furthermore, key European organizations and institutions have come up with reports, guidelines, roadmaps aiming to give guidance in this emerging and important health research field amongst others the European Science Foundation (ESF) Forward Look, the Manifesto of the European Alliance for Personalised Medicine (EAPM), the European Best Practice Guidelines of the Public Health Genomics European Network (PHGEN), the Roche report on Personalized Medicine or the report of the European Hospital and Healthcare Federation (HOPE). Based on these initiatives European and national decision-makers and funding bodies not only have expressed the urgent need for a CSA, but also initiated this specific CSA to step up coordination efforts between the European key stakeholders to allow synergies and avoid duplication or competition, to ensure maximum transparency and openness preparing Europe for leading the global way.