The Lancet Child Adolescents Health published the article ‘Strengthening children's participation in their health: the new initiative of the Council of Europe’ which was written by the TEDDY Chair, Annagrazia Altavilla, together with its colleagues from DH-BIO and CDENF Committees of the Council of Europe. According to the UN Convention on the Rights of the
The Contemporary Clinical Trials Communications journal has published the article: ‘Paediatric clinical research in Europe: An insight on experts’ needs and perspectives’ which concerns the results of a cross-sectional, closed-ended questionnaire prepared within the H2020 Paediatric Clinical Research Infrastructure Network - PedCRIN project. Within the project, TEDDY in collaboration with CVBF, is responsible for the
Last February 11, 2021, the European Forum for Good Clinical Practice (EFGCP) organised the webinar “Paediatric Clinical Trial Preparedness: New Enpr-EMA Guideline”. The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has been commissioned by the EMA Paediatric Action Plan to release a new guidance document in order to set out recommendations
The European Reference Networks for Rare Neurological Diseases (ERN-RND) and Neuromuscular Diseases (ERN EuroNMD) together with the European Academy of Neurology (EAN) has organised an educational webinar on Myoclonus dystonia focused on paediatric. Myoclonus dystonia can begin in the first 20 years of life and affects neck, arms and trunk but it can also occur
The EU is revising the rules on scientific and technological developments regarding blood, tissues, and cells for medical treatments and therapies. On 21 January 2021, the Commission launched a public consultation to collect the views of all interested citizens and organisations that will remain open until 15 April 2021. The consultation concerns an initiative for
On February the 2nd 2021, the Frontiers in Medicine journal (Impact factor 3.9) published the article named ‘Paediatric Medicines in Europe: The Paediatric Regulation—Is it Time for Reform?’ The article, written by regulatory experts from the TEDDY Network, is aimed at verifying if the European Paediatric Regulation (EC) N° 1901/2006 satisfies the paediatric therapeutic needs
Consent requirements are not harmonised in Europe and vary according to national laws and regulations. These discrepancies can present challenges for paediatric clinical trials, especially as many are conducted as multinational trials. The Enpr-EMA working group on ethics, of which Viviana Giannuzzi and Cristina Manfredi are members representing the TEDDY Network, has published the “Assent
Within the European Joint Programme on Rare Diseases (EJPRD), Pillar 3 WP15, TEDDY is responsible of the preparation for the educational materials and training activities for the paediatric patients. Education of young people is essential to incorporate them as advisors along the drug development process. A patient-centred approach can improve the capacity of collaboration with
In full COVID-19 emergency, most scientific studies have focused their research on adult patients. New drugs, vaccines and transmissibility factors were only analysed in the case of adult patients and children and adolescents were given little consideration. As it is appropriately indicated in the article: It’s Time to Put Children and Young People First During
The WHO has initiated a comprehensive gap analysis of the most needed medicines for children in view of its upcoming review of the Essential Medicines List for children (EMLc). To support the WHO review of the Essential Medicines List for children, the Global Accelerator for Paediatric formulations (GAP-f), a WHO-led network focused on achieving Universal