Avicenna Alliance Members Case Studies on in silico medicine

What can CM&S accomplish? Nothing short of redefining terms like ‘patient safety’, ‘efficacy’ and ‘cost effectiveness’ by forever raising the quality of data needed to meet high standards.

To do this we need to demonstrate what can be already done to give an idea of what we could do in future with the right regulator support and uptake across the healthcare sector.

The case studies in this document give but a glimpse of the potential that has yet to be unleashed by modelling and simulation.

Avicenna Alliance White Paper - Modelling And Simulation As A Transformative Tool for Medical Devices: The Transatlantic Regulatory Landscape

This White Paper highlights the potential of computer modelling and simulation in medtech and the regulatory and political barriers to unlocking that full potential.

Developed by Members of the Avicenna Alliance from the Medtech and Software sectors as well as the FDA, this paper is the starting point for a much needed discussion on how the policy framework governing the healthcare sector can be reformed to adapt to the technologies of the digital age that can in turn be put to use to solve some of the greatest healthcare challenges facing society.

This paper was official launched in the European Parliament on 04 September 2018 and is addressed to policy makers and regulators familiar with existing EU regulatory structures as well as those experienced in the medtech or software spheres.

In silico medicine in Europe

The undersigned, in their capacity as representatives of the VPH Institute, and of the Discipulus, INBIOMEDvision, PHS Foresight, CaSyM, and Avicenna support actions funded by the European Commission in the domain of in silico medicine, as well as the IMI-eTRIKS Consortium agreed to release the following joint statement: The use of information technology in healthcare is progressively expanding from its initial role of managing administrative information into that of support for the provision of care, whether related to prevention, diagnosis, prognosis, or treatment … 

Data Protection Regulation

On 12 March 2014, the European Parliament voted on its position on the new European Union (EU) proposal for a General Data Protection Regulation, which will be now negotiated among the European Parliament, the Council of the European Union and the European Commission [1]. The final text will set the rules under which personal data are to be handled in the EU. It will thus affect many areas of our everyday life, including health and research. The cancer community is deeply concerned about unintended consequences of the current wording of the draft Regulation [2], which may put at stake the survival of retrospective clinical research, biobanking, and populationbased cancer registries in the EU …

Position paper on animal experimentation for scientific purposes

In a context of ageing societies, the general public demands better treatments targeting the most common but also the most rare diseases, chronic and curable conditions, without compromising public health protection and ensuring the efficacy of the new treatments. European and national regulators have been working in the area of safety, quality and efficacy of the new medicinal products. This was reflected in European legislation requiring the conduction of toxicity tests on animals …

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