The latest UEMS council meeting took place in Brussels on April 12-13. Whilst hardly a riveting meeting, paediatrics were well represented there in a number of areas. Two further training programs (ETRs) were up for UEMS approval – Gastroenterology and Emergency Medicine – to add to the three that were agreed last year. With several more in the pipeline (such as neonatology, respiratory and renal) we will soon be over half way to having all our syllabi complete and up to date. We have already had some good feedback on the ETRs and we look forward to getting them finalised.
There is also the first meeting of the Multidisciplinary Joint Committee (MJC) in adolescent medicine. The response from other groups has been astonishing – over 30 people have expressed their interest, which is very exciting. Pierre-Andre Michaud has drafted outline objectives, and Karoly Illy, Artur Mazur and Helena Fonseca will help ensure that paediatrics has a very strong voice in the group. Other MJC activity includes the immune mediated diseases group where Tadel Avcin is joining as a paediatrician, and the infectious diseases MJC where Theoklis Zaoutis is joining. EAP is very happy to have more widespread representation on these groups.
Lastly we are expecting to finalise the protocol for centre visitation at the Spring Meeting in May. Details will follow in the next newsletter!
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.
