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Primary Care Permanent Council

Primary Care Paediatrics deals with new-borns, infants, children and adolescents in outpatient or ambulatory settings like public health clinics, health centres and solo or group practices, under the National Health Service system or privately. It includes all aspects of prevention, diagnosis, management and rehabilitation, extending to the somatic, psych affective and social sphere, as well as health promotion and advocacy.

 

The aim of this council is to increase the quality of paediatric care provided at primary care level. It is important that all care shall be as evidence-based as possible and that a high quality of care should be reached all over Europe. To achieve this, training programs and ongoing medical education are corner stones.

Agendas

Primary Care Council

Minutes

Spring

Winter

DOCUMENTS OF PRIMARY CARE COUNCIL

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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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