Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections, medical devices are crucial in diagnosing, preventing, monitoring and treating illnesses, and overcoming disabilities. Medical devices within the
In order to support the sharing of information on performed or planned studies and increase the efficiency of research, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency (EMA) strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register available
A pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organisation Country Office in China on 31 December 2019. After just three months WHO characterised COVID-19 as pandemic, currently affecting 157 countries and territories around the world. Besides the impact on international financial market and individual social life, COVID-19
The activities of the Italian Young Persons Advisory Group (YPAG), KIDS Bari, keep on and this year will be focused on the development of a serious game on the theme of Paediatric Clinical Research and Clinical Trial Center, as a playful training tool for the young members of the YPAGs and for paediatric patients. Moreover,
EPTRI (European Paediatric Translational Research Infrastructure) has announced the EPTRI Open Meeting that will be held on April 2-3 April 2020 at the President Brussels Hotel. EPTRI is an EU funded project coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche and aimed to design the framework for a new infrastructure dedicated to paediatric research that
In June 2014, IntechOpen Book, one of the world’s leading publisher of open access books, published the book entitled “Drug Discovery and Development - From Molecules to Medicine”, including a chapter written by Professor Adriana Ceci and experts from Gianni Benzi Foundation and the TEDDY Network. The chapter, entitled “Clinical Trials in Paediatrics — Regulatory
On January 2020, the European Medicines Agency (EMA) published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. In
Even this year TEDDY Network supports the Rare Disease Day, the thirteenth edition of the international initiative promoting awareness-raising activities on Rare Disease and that took place on 29 February 2020. The first Rare Disease Day was celebrated in 2008 on 29 February, a ‘rare’ date that happens only once every four years. Ever since
In November 2019, the Committee for Medicinal Product for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deferasirox Accord, a generic product of DESFERAL Novartis, intended for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias.
In March 2019, the Committee for Medicinal Product for Human Use (CHMP) on the basis of the draft Committee for Advanced Therapies opinion, adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynteglo, intended for the treatment of transfusion-dependent b-thalassemia (TDT). Since b-thalassaemia is a rare disease, Zynteglo was
