The European Medicines Agency (EMA), in collaboration with European healthcare professional organisations and learned societies, including the EAP Immunisation Strategic Advisory Group, is introducing a new communication tool on vaccines: Vaccine Essentials.
This initiative focuses on key topics in vaccine science and regulation, including the use of real-world data, and aims to address common questions and information gaps identified by healthcare professionals. It also highlights how vaccines contribute to reducing the burden of infectious diseases.
The first Vaccine Essentials focuses on meningococcal B (MenB) vaccines and has been co-created with the European Academy of Paediatrics (EAP).
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.
