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Recent Webinars

Choosing Wisely in Paediatric Practice: From Cognitive Bias to Collaborative Decision-Making

17 July 2025

Presenters:
Gabriel Brändle
Alessandra Montemaggi
Sandra Trapani
Sara Renzo
Fliss Stephenson
Moderator:
Alia Amira Ghazzawi
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Breathing Easy : Prioritizing Children's Health on Clean Air Day

19 June 2025

Presenters:
Laura Reali
Károly Illy
Helena Clements
Fliss Stephenson
Moderator:
Lorenza Onorati
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Every Childhood Matters Tackling the Hidden Dangers of Alcohol​

15 May 2025
Presenters:
Catherine Paradis
Frank Murray
Ann de Guchtenaere
Moderator:
Suleyman Yildiz

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Resurgence of Measles and Pertussis in Europe and Globally

17 April 2025
Presenters:
Hans Jürgen Dornbusch
Zoi Dorothea Pana
Moderator:
Berthold Koletzko



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Core-MD Project

Coordinating Research and Evidence for Medical Devices (CORE-MD)

New ways to test high-risk medical devices.

 

Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.


It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.

EAP Representative:

  • BERTHOLD KOLETZKO
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