On 10 September 2020, Executive Committee members of the European Academy of Paediatrics (EAP) met with the European Commissioner for Health and Food Safety, Stella Kyriakides.
The virtual meeting with Commissioner Kyriakides touched upon important child health issues and challenge, such as increasing vaccine confidence and the need for European-wide child and adolescent health data as part of the EU’s flagship yearly Health Maps. Likewise, EAP will provide feedback, from a child health perspective, on both DG SANTE’s upcoming Pharmaceutical Strategy and Evaluation of the Paediatric Regulation.
EAP also shared with Commissioner Kyriakides and her Cabinet members the EAP ‘Protection, Play, Education’ (PPE) recommendations , which include actions to be taken by the EU and member states governments to counter the effects of COVID-19 on the health and wellbeing of Europe’s children and put their interests higher in the political agenda.
Although initially published in July, the PPE recommendations remain just as pertinent in the COVID-19 recovery context, especially as children and adolescents prepare their return to school in many European countries. The pandemic has caused a decreased in vaccination rates amongst children, and increased physical abuse, self-harm, and obesity cases. In short, the inequality gap has widened, and cognitive and social development has been affected. In order to mitigate these potentially devastating effects and ensure the best possible future for our most precious asset, governments and institutions must act; and the EAP stands ready to support them and work with them.
EAP would like to thank Commissioner Kyriakides and her Cabinet once again for their time and support, and is looking forward to continuing this fruitful cooperation.
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.
