The bi-annual European Academy of Paediatric Societies (EAPS) Congress was held in Paris in the beginning of November this year. Co-organised by EAP, ESPNIC and ESPR as the three major stockholders – but with many other European societies involved in its organization -, this major education and research platform gathered representatives over 3500 participants from all over the world.
The congress was held in the Palais de Congress de Paris and was well-organised, hosting almost 3500 participants from all over the world.
The topics discussed during the EAPS Congress represented the variety of the paediatrics field, from primary to tertiary care paediatrics, from the clinics to basic research. The event days were split into plenary sessions and parallel sessions, which also gave young participants the possibility to present their research work.
EAP looks forward to, and welcomes you to join us in, the next EAPS Congress, which will take place in Barcelona in 2020.
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.