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August 2019

Avicenna Monthly Newsletter 

Key highlights

  • Congratulations to the Avicenna’s working group members that obtained the prestigious FDA award for the development of the V&V 40 standard!
  • The Avicenna Alliance answers online consultation to shape Horizon Europe's priorities: the submission is publicly available here
  • Save the Date: on 11 October 2019 ANSYS, US FDA, and the Avicenna Alliance are organizing a roundtable discussion in Washington, titled "Innovation Through Simulation in Healthcare". Register here to reserve your spot!
Policy Updates
Leaked document on Commission priorities 2019-2024 

On 23 August, a draft document on the Commission priorities for the years 2019-2024 has been leaked. This document containing the DG’s proposals is an internal and unofficial draft. For the time being, it has not been considered by the political hierarchy of the Commission, nor by President-elect Ursula von der Leyen or her transition team.
This document is however relevant, since here the competent Commission’s officials express their views on how to move forward on key policy priorities.
We discover that DG RTD, in cooperation with DG CNECT and GROW among others, are proposing to launch a “European Future Fund (EUFF)” to protect EU strategic interest by supporting European champions that create and develop new technologies. The ambition is to regain a leadership position in the global digital agenda.
 
For more information, please feel free to contact the Avicenna Secretariat.  

Advocacy

Avicenna answers online consultation to shape Horizon Europe's priorities 

The Avicenna Alliance took part in the online consultation and provided feedback on the Commission’s orientation paper in preparation for its 2021-2024 Strategic Plan for Horizon Europe. This was an important opportunity to highlight the need for funding of CM&S technology for the upcoming four years under Horizon Europe. The full text of the Avicenna’s submission can be found on the Avicenna website.
 
Avicenna’s member that are interested in participating in the consultation can still do so until the 8 September 2019 (link to consultation).  

 

Belgian Koenraad Norga elected as new Chair of EMA’s Paediatric Committee

At its July 2019 meeting, the EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served the maximum of two three-year mandates.
 
Professor Norga is hence to be considered as an important interlocutor when the Avicenna Alliance will have finalised its Position Paper on the added value of CM&S for Paediatrics.

Scientific and Regulatory News
Successful application of CM&S in clinics and eye surgery

A recent article published in the Journal of Cataract and Refractive Surgery, shows the successful application of Optimo Medical’s digital twin technology in clinics and eye surgery. It in fact concludes that using numeric modeling to optimize surgical parameters for arcuate keratotomy led to more reliable postoperative astigmatism, limiting the risk for overcorrection.

Funding Opportunities
European Commission launches tender for studies on AI and E-Health
 
On 7 August, the European Commission launched a tender for two studies to survey and analyse progress on the digital transformation of the health and care in the EU.
 
The call for tender specifically relates firstly to a study on citizens’ access to their electronic health records (EHR) in the EU Member States and secondly to a study on the development, adoption and use of artificial intelligence (AI) technologies in the health and care sector in the EU. Applicants are free to apply for one or both lots with the maximum amount allocated to the studies being EUR 300,000 for Lot I and EUR 200,000 for Lot II.
 
The deadline for reception of tenders is set for 23 September 2019 at 15:00.
News from Members
Prestigious FDA award allocated to group that developed the V&V 40 standard
 
The Avicenna Alliance is proud to announce that some of its working group members have received the FDA Crosscutting Group Honor Award on 2 August 2019. 

The language of the award stated that the awardees were being recognized “for exemplary performance in developing and establishing the first international standard for verification and validation of biomedical computational models for medical products”. 
 
More specifically, the award acknowledged the successful partnership between the US FDA’s Center for Devices and Radiological Health (CDRH) and multiple stakeholders across the medical device industry to develop the ASME V&V 40-2018 Standard. Full article can be read here.
Dassault Systèmes signs Research Agreement with the FDA
 
Dassault Systèmes and the U.S. Food and Drug Administration have concluded a five-year extension of their collaboration on the 3DEXPERIENCE platform in order to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices.

The project with the Living Heart simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This new digital process is intended to be more efficient and less expensive than current ones, whose delays and costs can impede patient access to novel treatments.
 
More information can be found on the Avicenna Alliance’s website.
Events and Webinars
Digital Excellence Forum @ ICT Proposers' Day 2019

19-20 September, Helsinki. DG CONNECT is organising a two-days event to present and discuss the main policy drivers of the digital transformation of European industry and society, and how the EU research and innovation agenda can best contribute to these objectives.

To consult the agenda click here. If interested, you can register by 18 September (you need a EU login account).
Innovation Through Simulation in Healthcare

On the 11 October 2019 ANSYS, US FDA, and the Avicenna Alliance are organizing a roundtable discussion in Washington, focusing on modeling and simulation in the medical device and pharmaceutical industries.  

The goal of the meeting is to discuss opportunities and challenges when utilizing in silico approaches during development and regulatory review.  The event will be organized around 2 panel discussions, where senior leaders from the largest medical device and pharmaceutical companies will be sharing their experience and expectations.
 
Please register here to reserve your spot!
KCE event in Clinical Trials

The Belgian Health Care Knowledge Centre is organising the Symposium on 28 November in Brussels titled: “Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Data Sharing”.

The draft agenda can be found at the following link.
 
Click to subscribe - Closing date for subscriptions is 14th November.
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