The European Academy of Paediatrics (EAP), through its work in collaboration with the UEMS Subspecialty Societies, is pleased to share that several European Training Requirements (ETRs) in paediatrics will be presented at the upcoming UEMS Council Meeting in Tunis.
These include ETRs for key paediatric competences:
The development of ETRs represents a significant commitment to strengthening paediatric education, supporting workforce development, and ultimately improving the quality of care for children across Europe.
The EAP would like to express its sincere appreciation to all contributors involved in the preparation of these documents a process that has required many months, and in some cases years, of dedicated work.
Special thanks are extended to the colleagues presenting these ETRs in Tunis:
The EAP community is encouraged to follow the outcomes of the Council Meeting, with further updates to be shared in due course.
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.
