News
Slovenian Presidency of the Council of the EU launches its six-month programme!
On 1 July, for the second time since joining the EU in 2004, Slovenia has taken over the Presidency of the Council of the European Union. Slovenia is part of the 10th Presidency Trio, together with Germany and Portugal. The slogan shaping the programme of Slovenia’s Presidency is "Together. Resilient. Europe."
Members of the European Parliament call EU Health Commissioner to place in silico medicine on her policy agenda from 2021 onwards!
On 22 June, a group of five Members of the European Parliament (MEPs) sent a letter to Commissioner for Health, Stella Kyriakides to call for action on computer modelling and simulation (CM&S). The groups of MEPs representing the main political parties within the European Parliament, MEPs Sean Kelly (European People’s Party, Ireland), Frédérique Ries (Renew Europe, Belgium), Brando Benifei (Socialists & Democrats, Italy), Margrete Auken (Greens/European Free Alliance, Denmark), and Pietro Fiocchi (European Conservatives & Reformists, Italy) co-signed this letter with the aim of outlining why regulatory guidance is urgently needed to make European healthcare systems and patients fully benefit from in silico technologies. Particularly, the letter addresses how CM&S can initiate major progress in health care, such as in the fields of rare and paediatric diseases and health system sustainability. In that context, it demonstrates by means of tangible examples that the policy frameworks currently in place are not sufficient for these technologies to advance.
Our new position paper on in silico evidence in the regulatory approval of medical devices is out!
The Avicenna Alliance is proud to announce the recent publication of its new position paper entitled Ensuring the Quality of in silico Evidence: Application to Medical Devices. This document provides a broad explanation of the opportunities and benefits of in silico methods while also drawing attention to the urgent need for a harmonised regulatory approach supporting the acceptance of in silico evidence included in device submissions. The paper then outlines a risk-based framework for establishing the credibility requirements of in silico evidence used during regulatory decision-making.
Happy 5th Anniversary to the Avicenna Alliance!
5 years ago, based on the very enlightening Avicenna Roadmap Project Report, the Avicenna Alliance was established at the suggestion of European authorities. The initial goal was to guide authorities towards a safe and cautious, but efficient, adoption of in silico methods. The initial members were a few industrial companies who joined forces with the VPH Institute to tackle this very ambitious goal.
EU New Medical Device Regulation now in force! In silico mentioned for the first time
After a one-year postponement following the COVID-19 pandemic, the European Commission’s Medical Devices Regulation (MDR) entered into application on 26 May. The implementation calls attention to the need for enhanced availability of vitally important medical devices across the EU. Accordingly, the MDR pursues the development of a more adequate regulatory framework by improving the safety and quality of medical devices. It also seeks to provide increased transparency for patients and less administrative burden for companies. When it comes to potential implications for in silico medicine, it should be noted that the dossier specifically provides the possibility of submitting computer modelling and simulation (CM&S) data to notified bodies. As such, the implementation of the MDR could give rise to a significant boost for in silico medicine applications. However, to date no legislation was established yet on the verification and validation of these models, the assessment of simulation results, nor on standard requirements of medical device companies when submitting CM&S data to support a market authorization or when seeking reimbursement.
The European Commission adopts Communication on Europe's global approach to cooperation in research and innovation
On 18 May, the European Commission adopted a Communication on its global approach to research and innovation, entitled Europe's strategy for international cooperation in a changing world. This Communication will supersede Europe's previous strategy for international cooperation in research and innovation as a response to today's significantly different global context and align the EU's international cooperation with its current priorities.
