EAP Executive Committee Member and Chairman of the European Board of Paediatrics (EBP), Dr. Robert Ross Russell, is planning the upcoming “Healthy Child, Healthy World” event, a week of celebration of child achievements in Cambridge that will be run in October this year. The format is to hold daily events (flashmob, music, exercise class) alongside information around issues of international importance (malnutrition/obesity, child refugees, child exploitation, …).
“Healthy Child, Healthy World” is supported by, and will feature in its activities, renowned medical personalities such as Dr. Waheed Arian and Dr. Rachel Furley, in what is it bound be a remarkable and widely covered event. You can keep up with all the latest developments by following @HealthyChildHW on Twitter.
In order to make “Healthy Child, Healthy World” a truly European event, any EAP supports who are interested in running a similar event in their own country/region over the same week should contact Dr. Robert Ross Russell.
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.
