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 Policy Working Group Mission is to work towards:
Ø A forward-looking policy framework to facilitate the large scale deployment of in silico technology and their acceptance by health authorities.
Ø To significantly reducing time and cost for health care technologies approval and reimbursement and fostering medical innovation, including for those conditions with pressing unmet medical needs such as rare diseases and pediatric applications.
The key goals of this group are:
- Inform European and US authorities about the benefits brought by in silico medicine;
- Advocate for the inclusion of CM&S (Computer Modelling and Simulation) in legislation, policy guidelines and research funds;
- Collaborate with health care stakeholders on in silico guidance and CM&S benefits dissemination, ensuring that in silico clinical trials become a pillar of drug and medical device development programs, when appropriate.
Priorities 2021 - 2022
- Engagement with EMA towards a White Paper on Verification and Validation
- Engagement with Notified Bodies
- Promotion of GSP vis-à-vis European and American policy-makers
- Advocate for in silico medicine use to stakeholders (authorities, pharma / MedTech companies, patients, etc.)
- Develop communication strategy (e.g., white paper, webinar, social media)
- Work with EMA and FDA to establish GSP