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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, Edwards Lifesciences

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NEWS

News Avicenna Alliance at RAPS meeting in Pittsburgh

Avicenna Alliance at RAPS meeting in Pittsburgh

On October 8th, various key members of the Avicenna Alliance including Marc Horner, International Affairs WG leader, Martha de Cuhna, Policy Development WG Leader, and our new partner Surash Surash from the leading Notified Body TüV SüD, spoke at the Regulatory Affairs Professional Society (RAPS) meeting in Pittsburgh to highlight the essential and increasing role of in silico methods throughout the total product life cycle of medical devices.

News Avicenna Alliance Welcomes the Notified Body TÜV SÜD as a New Partner

Avicenna Alliance Welcomes the Notified Body TÜV SÜD as a New Partner

The Avicenna Alliance is delighted to welcome TÜV SÜD as its newest Partner. TÜV SÜD is a leading Notified Body operating across multiple regulatory territories, including the EU, the United States, the UK, and Asia. With more than 150 years of experience, a presence in 1,000 locations worldwide, and over 30,000 employees, TÜV SÜD is a trusted global partner in testing, inspection, certification, and training solutions.

News The Alliance at the iSi Health Symposium

The Alliance at the iSi Health Symposium

On 11 and 12 September 2025, our partner iSi Health, Erica Beaucage-Gauvreau and Rocio Castro Vinuelas, organised an excellent symposium in Leuven to bring together key players in the in silico community and promote networking, brainstorming and exchanges.

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