May 18, 2023 @ 8:00 am – May 21, 2023 @ 5:00 pm CET
This Event Passed
Dear Colleagues,
After careful preparation, and a commitment to “being different” from other paediatric conferences, the EAP Congress and MasterCourse over the past few years, despite an ever-increasing number of conferences in Paediatrics, has attained a very special reputation.
Over one-and-a-half days, based on most recent publications, the conference presents a fantastic workshop, named Mastercourse in Paediatrics. The MasterCourse this time will be focused on “Acute ill child”. The scientific chairmen, Prof. Liviana Da Dalt together with the scientific committee of the Mastercourse have prepared an excellent programme with famous faculty members. Mastercourse in Paediatrics take place in relatively small break-out rooms with only limited seating capacity. I, therefore, recommend early registration.
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.