Abstract

As The EPMA Journal has already reported, in 2010 the EU-Commission has triggered consultations with the leading experts who are actively developing innovative bio/medical technologies and promoting the field of personalised medicine. From April till June 2010, the series of workshops was signed and organised by the EU-Commission as the “Vision 2020” in Brussels aiming to elaborate the items which will be fundamental to develop personalised medicine for us—European citizens in the new frame-programme Common Strategic Framework (also known as FP-8) during the next 10–15 years beginning with 2013. Upon the invitation by the EU-Commission, several EPMA-experts have been involved in the creation of the items. Summarising protocols of these consultations have been published on the website of the EU-Commission. Now it is time to approve the elaborated programme for personalised medicine in the new frame-programme. The finalising meeting “European Perspectives in Personalised Medicine” was open to all and took place in Brussels on May 12–13th 2011—see the announcement by the EU-Commission in Fig. 1. Fig. 1 European event of the global meaning: “European Perspectives in Personalised Medicine” is the workshop organised by the EU-Commission in order to finalise the priorities and items for personalised medicine in the new Common Strategic Framework ... The following topics were discussed: The role of “omics” research and technologies in the development of personalised medicine—opportunities for clinical utility Biomarkers in personalised medicine: key challenges in identification, validation and qualification of safety and efficacy biomarkers Clinical research and trials in personalised medicine—needs and considerations The regulatory framework and personalised medicine: approval process towards the market and patients Post-approval process: cost-benefit approaches and uptake in healthcare systems Implementing personalised medicine: practitioner and patient perspectives, availability, awareness, resources and needs. In order to discuss the final items, the EU-Commission has nominated representatives of the main stakeholders and leading professional groups. Among them, three of EPMA-associated experts have been invited to comment on and to contribute to the corresponding topics: Prof. Dr. Romano Danesi, The National EPMA-Representative in Italy, Prof. Dr. Charles Swanton, The National EPMA-BOARD in UK, Prof. Dr. Olga Golubnitschaja, Editor-in-Chief of The EPMA Journal & Secretary-General of EPMA. The audience has appreciated the contribution by the EPMA-Representatives. The key challenges, needs, topics and corresponding items promoted by EPMA for specialised calls (budgets) in the new programme, that have been taken into the final protocols by the EU-Commission, are summarised below.

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