To reinforce perceptions of EAP as the voice of children’s health in Europe, we have been collaborating with LOWeurope, a Brussels-based consultancy specialising in strategic advice, marketing communications (such as PR and social media) and event management.
This successful collaboration, which began in 2017, has already contributed greatly to having more effective and authoritative EAP communications: for example, the “EAP News” newsletter, EAP’s social media channels, and several multimedia/visual documents on EAP priority topics.
Upcoming initiatives will include a re-organisation of the EAP website, as well as a focus on research & training opportunities in paediatrics-related areas.
LOWeurope’s Managing Director, Sally Low, said the company was ‘delighted to be working on such a worthwhile, fascinating and prestigious project with EAP’s dynamic team of experts’.
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.
