ABOUT

Secondary – Tertiary Care Council

The Secondary/Tertiary Care Council serves the scientific, educational, professional and practice-based interests of secondary/tertiary care paediatrics, including all hospital based paediatrics. It provides representation of secondary/tertiary care to the European Board of Paediatrics, relevant task forces and strategic advisory groups. The chairperson of this Council is a member of the EC. National delegates, paediatric subspecialty societies and related societies, and individual active, affiliated and honorary members with a related interest in specific areas contribute to the ctivities of the Secondary/Tertiary Care Council. The group is responsible for maintaining European Training Requirements documents for the paediatric subspecialties. They  are developed with the European paediatric subspecialty societies, are presented and discussed with Secondary/Tertiary Care Council, and after agreement forwarded for approval to the EAP General Assembly. At present 14 different paediatric medical subspecialties are recognized within Europe. Discussion within the group also contributes to shaping a common paediatric training concept – including the relationship of subspecialty training to core paediatric training – the ‘Common Trunk’.  

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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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