EAP has created its own detailed guidelines on the health risks and needs of refugee and migrant children entitled Providing primary care for migrant children in Europe. Seeking to provide optimal care for migrant and refugee children in need of paediatric treatment, the publication of the Guidelines (which contain 12 guidelines in all) was preceded by a comprehensive survey carried out by EAPRASnet (check our EAP Members News section for further information). The Guidelines shall be published in The Lancet in the beginning of 2018.
The publication of the Guidelines follows the release of ISSOP’s Budapest Declaration for Children on the Move, of which EAP is a signatory. Approved during ISSOP’s Annual Meeting (held on 28th-30th September in the Hungarian capital), the Budapest Declaration 2017 primarily focuses on children on the move and their health and well-being. The document states that ISSOP and its members will implement practical guidance issued by the UNHCR and the Global Migration Group (GMG) in 2017.
To read the Budapest Declaration for Children on the Move, please click here.
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.
