The European Society for Paediatic Gastroenterology, Hepatology and Nutrition (ESPGHAN), a long-standing and active EAP member association, celebrated 50 successful years since its creation. ESPGHAN started in 1968 as a group of 36 friends, who held an informal meeting with some 20 oral presentations to share their work in the clinic and in the laboratory. It has grown over the years into what is now an extremely strong, highly professional and globally impactful organisation dedicated to research and clinical care related to gut, liver and nutritional health of infants, children and adolescents.
This year’s annual congress was held in Geneva, Switzerland, in May, and celebrated the occasion with over 4600 delegates from 100 countries around the world. ESPGHAN’s history, recent developments and future opportunities have been summarised in a special supplement of the society’s journal, published on the occasion of its 50th anniversary.
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.
