The European Commission has tasked the Avicenna Alliance with meeting a significant challenge – developing recommendations and plans for the implementation of the Avicenna Roadmap in policy.
The Policy Development Working Group aims to work towards the inclusion of Avicenna Alliance members’ interests in EU policies. Many EU policies, Directives and Regulations predate the existence of the very same in silico technologies they are designed to govern.
In order for the in silico market and research community to be enabled, current policies and legislations governing healthcare need to be updated. The creation of a framework for the validation of in silico models and the acceptance in the Regulatory system of data derived from modelling and simulation is a prerequisite for further investment in this field and the realization of its potential.
The key goals of this group are:
- Identification of challenges for the in silico market and research community and the development of corresponding policy solutions;
- Engagement with the European Parliament, Council and Commission on key dossiers and policy issues of importance to the Membership;
- Communicate on the potential of in silico medicine for patients, healthcare professionals and industries.
Priorities in 2017
→ Coordinate and contribute to the Avicenna Alliance Policy Recommendations on in silico medicine to be submitted to the European Commission;
→ Advocate for the inclusion of a framework for the validation of in silico clinical trials in Reopened EMA Regulation;
→ Advocate for maintaining the current Council text on the Medical Devices Regulation with regard to the inclusion of modeling and simulation data in applications to a notified body