COVID-19 SERIES (#3) Suffer the Little Children? This is the fourth in a series of Dr. Rob Ross Russell’s brief musings on aspects of the COVID-19 crisis. They are all my personal views and should not for a moment be interpreted as advice or dogma –…
February 2020 Rare Diseases, Everyday Efforts. February 29th is Rare Disease Day. EAP has decided to dedicate this month’s blog to the challenges of rare diseases in paediatrics across Europe. the situation In Europe, a rare disease is defined as one…
January 2020 Towards the harmonisation of paediatric training in Europe. January 24th is the International Day of Education, so it seemed fitting that EAP has decided to dedicate this month’s blog to the educational challenges of paediatric training…
November – December 2019 Access to medicines for children. What’s the situation and how does this affect children? Millions of children still die every year before the age of 5, worldwide, due to treatable conditions. Poor access to essential medicines…
October 2019 Commissioner Vytenis Andriukaitis: The futute of child health in Europe. This month, EAP and Young EAP are honoured to have the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, authoring a special blog article on the…
September 2019 Cleaner air for healthier children. In October/November 2018 WHO will convene the ‘First Global Conference on Air Pollution and Health’, which will bring authorities, policy makers, health professionals and other relevant entities…
september 2019 Cross-border research in europe: we can and should do more. The situation Despite ongoing improvements in child health across Europe, it still matters where you live in Europe as a child or an adolescent. Considerable differences between…
August 2019 Young EAP august 2019 blog: Εducation in vaccinology – a crucial tool to fight the vaccination crisis. «I feel that the greatest reward for doing is the opportunity to do more.» – Dr. Jonas Salk. Vaccination is widely…
July 2019 Adolescent medicine and health – a training challenge for europe? “We cannot always build the future for our youth, but we can build our youth for the future.” – Franklin D. Roosevelt A safe and successful transition from childhood into…
June 2019 Protecting children on the move – the pediatricians’ perspective. ‘History in its broadest aspect is a record of man’s migrations from one environment to another’ Ellsworth Huntington, Professor of Geography at Yale University,…
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.
