Dear all,
After spending seven years in the EAP Executive Committee – two as Vice-President and five as President – it is time to say thank you. It has been a pleasure and a great honour to serve the EAP and to have been trusted by all of you to serve as the EAP President.
It has been a challenge, and without the close collaboration, input, and work from the whole EC board, the task would have been impossible. I believe in a horizontal leadership style and strong participation of all the EC members to reach good results, and I think we have succeeded. During these five years as president, I have been part of a growing and thriving EAP. I will also take this opportunity to thank all EAP delegates and members for their constructive feedback and encouragement. Thanks to this, we have engaged in many new activities and improved existing ones.
I am confident that under the leadership of the new President, Professor Adamos Hadjipanayis, the EAP will continue to thrive, and have a strong impact in Europe in the near future, wherever children´s health and the professional life of paediatricians are concerned.
Tom Stiris, EAP
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.
