The Horizon 2020 “MOCHA – Models of Child Health Appraised” research project will have its final conference on 15-16 November 2018, in The Hague, Netherlands. The event will present MOCHA’s headline results, formal reports, and pave the way for stakeholder discussion on the next steps following the project’s conclusion.
With a total duration of three years, MOCHA has identified and critically assessed all aspects of primary health care provision for children of all ages in all the 30 EU/EEA countries. EAP has collaborated in MOCHA as member of the External Advisory Board. Morever, several EAP National Delegates have collaborated either as Work Package leader, MOCHA Country Agents, or by helping their Country Agent.
You can find all the Deliverables completed so far and registration information at website http://www.childhealthservicemodels.eu/
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.
