Publications

The new Avicenna 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.

The new Avicenna flyer is out!

The past few weeks, the Alliance has been working hard to develop a brand-new Avicenna flyer for public distribution. The flyer aims at giving anyone who is yet unfamiliar with the Alliance, a concise overview of its origins, purpose, activities, mission, and long-term vision. Moreover, the flyer explains why in silico is so important for the Alliance’s objectives, as well as what it could potentially bring to our future healthcare systems. All members are kindly invited to distribute the leaflet to anyone who could be interested.

Avicenna Alliance provided feedback on the Revision of the EU general pharmaceuticals legislation

On 27 April, the Avicenna Alliance has submitted its feedback to the revision of the EU general pharmaceuticals legislation. Through this feedback, Avicenna Members provided the European Commission with guidance on how to meet unmet medical needs, maintain a system of incentives, promote evidence generation tools for marketing authorisation of innovative medicines, and support and accelerate product development and authorisation. We encourage all members to have a read through the feedback given by the Avicenna Alliance which you can find in this PDF:

Avicenna Alliance provided feedback on the creation of a European Health Emergency Preparedness and Response Authority (HERA)

On 24 February, the Avicenna Alliance submitted its feedback on the creation of a European Health Emergency Preparedness and Response Authority (HERA) aiming to ensure a solid framework for EU preparedness and response to serious cross-border health threats.

read the feedback

Avicenna Alliance provided feedback on the inception impact assessment on the European Health Data Space

On 3 February, the Avicenna Alliance has submitted its feedback to the inception impact assessment on the European Health Data Space. With this feedback, Avicenna Members provided the Commission with guidance on how to ensure access to data, the interoperability of data and more importantly on which technical developments can enable us to turn the health data into actionable information, including in silico and AI techniques.

Avicenna Alliance provided feedback to the public consultation on European Medicines Agencies Network Strategy to 2025

On 4 September the Avicenna Alliance provided feedback to the public consultation on European Medicines Agencies Network Strategy to 2025!

The purpose of this public consultation was to seek views from EMA’s and HMA's stakeholders, partners and the general public on the proposed joint European Medicines Agencies Network Strategy to 2025 and whether it meets stakeholders’ needs.