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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

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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NEWS

News The European Parliament voted the reform of General Pharmaceutical Legislation (GPL)

The European Parliament voted the reform of General Pharmaceutical Legislation (GPL)

On April 10, the European Parliament overwhelmingly backed the reform of General Pharmaceutical Legislation (GPL), marking a pivotal moment in healthcare regulation. With a resounding majority, both the Directive and Regulation were embraced, reflecting a collaborative effort within the ENVI committee.

News The Avicenna Alliance warmly welcomes Tox By Design into its esteemed ranks!

The Avicenna Alliance warmly welcomes Tox By Design into its esteemed ranks!

Tox by Design is a prominent European toxicological expertise firm specializing in conducting toxicological Risk Assessments (RAs) for various industries such as biotech, pharmaceuticals, cosmetics, medical devices, and API synthesis.

News Marc Horner is the new Avicenna International Affairs Working Group Leader

Marc Horner is the new Avicenna International Affairs Working Group Leader

We are thrilled to announce that Marc Horner, Distinguished Engineer at Ansys, and Global Harmonization Task Force leader at the Avicenna Alliance, has been appointed as the new International Affairs Working Group Leader. Marc was already acting as a close partner of Nathalie Virag, former head of the International Affairs Working Group, recently appointed by Medtronic to prestigious responsibilities.

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