The European Board of Paediatrics (EBP) is delighted to be making progress on several fronts towards its full establishment and regular operations. Firstly, Robert Ross Russell (UK) (as the newly elected chair) is joined by Martin White (Ireland), who is the new Officer for Assessment and Examination and brings great experience to the role, having been involved for many years in the Irish examinations. Tommaso Alterio (Italy) is the EBP’s first Young EAP representative, and will help promote the exam and take the new plans forward.
Regarding the knowledge-based exam, the EBP had two teleconference meetings with a company which may be able to support its efforts. Likewise, discussions are also continuing with the Royal College of Paediatrics and Child Health (RCPCH) in the UK to explore the best way to develop a ‘European’ exam.
Furthermore, the EBP has proposed that the Union Européenne des Médecins Spécialistes (UEMS) – of which EAP is the paediatric section – set up a joint committee (a formal structure similar to the ‘Sections’) to consider adolescent medicine. Lastly, the EBP have established a group to look at training in intensive care medicine.
Any members interested in helping on the joint committee and/or the intensive care medicine training group should get in touch with EAP’s President Tom Stiris or 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.
