On 6 Sept. 2002, Dr. Peter Liese, Member of the European Parliament, and the EAP co-organised a stakeholder workshop in the European Parliament in Brussels addressing the hot topic “Breastfeeding promotion and a public-private partnership for infant nutrition – are they compatible?” Featuring speakers from EAP, WHO Regional Office for Europe, a Parent Organisation and a Dietetic Industry Association, the session sought to understand how breastfeeding is be promoted while simultaneously ensuring that mothers who do not provide breastfeeding receive evidence based and current information on substitute options. The panelists concluded that close collaboration and a relationship of mutual trust between paediatricians and other healthcare professionals, families, and the public sector is needed to achieve progress. The EAP will follow up on these conclusions in the near future.
The EAP thanks all the leaders of the Strategic Advisory Groups, National Delegates, Individual members, and collaborating societies for being a part of its accomplishments.
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.