Regulatory Bodies

Regulatory Bodies aim at ensuring the safety of all medicinal products and services that are offered on the market and, at the same time, at providing the best possible health services for the public. Clinical trials have become a major bottleneck in the development process of new therapies. At the same time technologies facilitating clinical trials are becoming increasingly significant.

Scenarios and structures that help to run more clinical trials and to bridge the gap between the treatment given to patients today and research striving to find a better treatment for patients is of utmost importance. A close cooperation of all stakeholders in the health care system will add a surplus in translational research by bridging this gap between basic research and clinical care.

p-medicine links and harmonizes its work with important European Research Infrastructure Initiatives in order to share resources and results, contribute to standards and toolkits, avoid redundant work, and integrate and disseminate its results within the respective communities.

p-medicine will provide a service oriented clinical research infrastructure that is smoothly interconnected and guarded by a legal and ethical framework. This framework will guarantee the safety and security of data and facilitate regulatory issues of clinical research. The system architecture needs to deal with secure and safe acquisition, storing, sharing, merging and analyzing of vast amounts of heterogeneous data coming from different sources. It is as important to handle reliable clinical data from hospital information systems (HIS) in p-medicine as it is to handle data from prospective clinical trials running under the umbrella of European regulations.

Why is p-medicine interesting for regulatory bodies? p-medicine aims to…

  • Improved life expectancy and quality of life through individualized of treatment
  • Better and rationalized health services for the citizen
  • Lower of the treatment cost per patient by avoiding non effective treatment schemes and/or schedules through the utilization of the expectedly rational predictions of the VPH multiscale and patient individualized models
  • Establish a legal/ethical framework for translational research
  • Facilitate international harmonization

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