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EMA Collaboration Task Force

EMA Collaboration Task Force

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EMA Collaboration Task Force

Mission: Closely collaborate with the European Medicine Agency (EMA) to inform them about the progress of in silico methods and learn about EMA requirements to accept digital evidence

The European Medicines Agency (EMA) plays a crucial role in supporting innovation and advancing the development of medicines within the European Union (EU) and its involvement with
in silico technologies. This aligns perfectly with the Avicenna Alliance aims to ensure that in silico evidence becomes an integral part of regulatory practice, benefiting patients and fostering healthcare breakthroughs.

The Avicenna Alliance collaborates with the EMA, along with other stakeholders, to advance
in silico methods and together they engage with European authorities to promote the role of in silico techniques.

In summary, the EMA Task Force actively collaborates with stakeholders to advance innovative approaches, including
in silico technologies, to enhance the safety and efficacy of medicines in the EU.

Goals

  • Publish a white paper about the use of in silico methods to provide digital evidences for pharmaceutical applications.
  • Informal small-scale closed meetings every 2 months to have fast communication on most interesting topics to work on.
  • Public Triple Helix expertise exchange workshops between EMA, industry & academia: first edition on drug-device interaction in Q2, follow up in Q3.


Liesbet Geris

Liesbet Geris

Research & Technology Working Group Leader

Executive Director, VPH Institute

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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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