We are happy to announce that TEDDY became a member of Enpr-EMA Coordinating Group. The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in...
EPTRI Open Meeting – find out the future frontiers of the paediatric research
The EPTRI Open Meeting on April 2-3 April 2020, due to Covid-19 outbreak, was run online. EPTRI is an EU funded project coordinated by CVBF and aimed to design the framework for a new infrastructure dedicated to paediatric research that will work to accelerate a...
TEDDY contribution in EJPRD. The activities foreseen in 2021-2023
In January 2019, the European Joint Programme on Rare Diseases (EJPRD) started its activities aimed to create a comprehensive, sustainable system allowing virtuous circle between research, care and medical innovation. TEDDY Network is among the beneficiaries of this...
EMA approves Nepexto for the treatment of juvenile idiopathic arthritis
On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto (etanercept), intended for the treatment of rheumatoid arthritis, juvenile...
EMA adopted an extension to the indication of Ruconest to include children from the age of 2 years and above for the treatment of acute angioedema attacks
On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ruconest (conestat alfa). The marketing authorisation holder for this...
The 10th European Conference on Rare Diseases – ECRD 2020 will be held online on 14-15 May
The 10th European Conference on Rare Diseases & Orphan Products (ECRD) will take place ONLINE on 14-15 May The ECRD is recognised globally as the largest, patient-led rare disease event in which collaborative dialogue, learning and conversation takes place,...
COVID-19: what is the current situation of the International Authorities
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...
European Commission working on proposal to postpone MDR application date for one year
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...
Registration of COVID-19 related studies in the EU PAS Register
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...
COVID-19: what is the current situation of the International Authorities
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...