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Policy Development (PD) Working Group

Policy Development (PD) Working Group

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Policy Development (PD) Working Group

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:

  • A forward-looking policy framework to facilitate the large scale deployment of in silico technology and their acceptance by health authorities.

  • 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 2023 - 2024 and beyond:

2023:

  • Establish collaboration with EC stakeholders;
  • Define pathway to submit digital evidence to support CE marking;
  • Define GSP in collaboration with FDA, EMA, MDIC and InSilicoWorld;
  • Promote in silico medicine for Pharmaceutical application;
  • Educate stakedholders via NB TF, Pharma Strategy and PPI TF.

2024:

  • Identify policies mentioning payers to promote in silico medicine
  • Foster collaboration with European Commission
  • Promotion of GSP vis-à-vis Worldwide Policy makers (with Int. WG);

2025 and beyond:

  • Sustain in silico advocacy for Medcial Devices and Pharmaceuticals

Martha De Cunha Maluf-Burgman

Martha De Cunha Maluf-Burgman

Policy Development Working Group Leader

Director Regulatory Affairs Digital Health, Edwards Lifesciences

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