On 02 May 2016, Avicenna Alliance delegates met with representatives of DG Connect to discuss progress on in silico medicine in the 1st quarter of this year.
The European Commission had good reason to be pleased at progress. The Avicenna Alliance has successfully engaged with policy makers on a number of key healthcare topics over the last number of months.
The European Parliament’s position on the revised EMA Regulation now contains an article calling on the EMA to work towards the acceptance of alternative models in clinical trials with a particular focus on modelling and simulation.
The current Council text of the Medical Devices Regulation now requires notified bodies to take into account what modelling and simulation data has been used the submission of a request for marketing authorization.
A clear result of Avicenna Alliance engagement with policy makers in raising awareness of the potential of in silico medicine, is that two of the most important pieces of ongoing legislation in the field of healthcare now factor in the needs of the in silico community.
This progress has not gone unnoticed and the FDA is looking toward joining the Avicenna Alliance seeing the Alliance as a potential interlocutor between the US and EU authorities on harmonization of policies on in silico medicine. With Membership of the Alliance growing, after only a few months of operation, the Alliance is already becoming a driving force of in silico medicine. In terms of next steps the Alliance will deliver a publication to the European Commission outlining the market and research barriers to the in silico community.
The Alliance also intends to be a key contributor to the review of the eHealth Action Plan in which in silico medicine is specifically mentioned.
The European Commission will also be represented at both the VPH Conference in Amsterdam in September and the Avicenna launch event in October of this year.
The successful cooperation between the European Commission and the Alliance is cause for celebration and the progress so far serves only to highlights the benefits of this cooperation. The Alliance now moves into its next phase – delivering through the working groups, development of key documentation and direct policy input over the coming months in advance of the Avicenna Alliance launch event.
For the latest information on in silico medicine follow the Avicenna Alliance twitter account.