To celebrate the European Immunization Week (23-28 April), a health initiative on the importance of vaccine confidence and increased immunisation rates by the WHO and the ECDC, EAP carried out a social media campaign in support of vaccination.
Statements from EAP representatives on increasing vaccine confidence, posted on Twitter throughout the EIW week, created high public interest and were widely shared by profiles of personalities like the EU Health Commissioner Vytenis Andriukaitis. All statements can be accessed and shared here.
EAP’s Secretary General, Dr. Adamos Hadjipanayis, also took part in the European Medicines Agency (EMA)’s #VaccinesWork video.
Furthermore, EAP/Young EAP’s March blog article focussed on the the unmet WHO goal of measles eradication in Europe (with a fourfold rise of measles cases from 2016 to 2017) as well as a review of the last influenza season with all circulating virus strains well covered by the 4-valent vaccine, however, with persistently low vaccination rates.
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.
