A Letter from the EAP’s President | January 2021

January 9, 2021

Dear Colleagues,

 

In 2020 we have all experienced the persistent suffering and grief, and everyone’s lives were marked by the COVID-19 pandemic.

 

The Covid-19 pandemic has increased inequality in society. It has magnified the social and economic disparities, and made the lives of vulnerable children (refugees, low income etc.) much worse.

 

Despite the national and European restrictions on travelling and the measures of social distancing, we have never stopped working to develop a better world for our children.

 

The European Academy of Paediatrics (EAP) has become with your support, following also the unanimous approval of the new Statute, a Pan-European Umbrella Organization, recognized internationally. It is the major advocator in Europe for all children and their well-being.

 

At the same time EAP works to protect and develop the profession of paediatrics in every European country irrespective of the national health system. The success of the first ever EBP pan-European paediatric exam means we are helping trainees demonstrate their expertise and facilitating uniform standards of training between countries. 

 

I am confident that we all agree that we should work together in unity and solidarity. Thus, I wish you all a time of cohesiveness, solidarity and joined work to develop a better future for our children, adolescents, and our profession.

 

With great appreciation,

 

Prof. Adamos Hadjipanayis

European Academy of Paediatrics

President

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Core-MD Project

Coordinating Research and Evidence for Medical Devices (CORE-MD)

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.

EAP Representative:

  • BERTHOLD KOLETZKO
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