The article ‘Susceptibility to SARS-CoV-2 infection among children and adolescents compared with adults’, published on JAMA Pediatrics, is the result of a systematic review and meta-analysis including 32 studies, children and adolescents younger than 20 years had 44% lower odds of secondary infection with SARS-CoV-2 compared with adults 20 years and older. Preliminary evidence suggests
The Clinical Trials Regulation (EU) 536/2014 is foreseen to become applicable at the end of January 2022. To support Member States with its implementation, DG SANTE of the European Commission, the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency jointly organised a training course on 9-10
As part of the EU pharmaceuticals strategy, and drawing lessons from the COVID-19 pandemic, the Commission launched an inception impact assessment to evaluate and revise the EU’s general legislation on medicines for human use to ensure a future-proof and crisis-resistant medicines regulatory system. TEDDY Network participated to the consultation providing its comments to be considered
On April 9th 2021, TEDDY network provided its feedback to the European Commission public consultation on the revision of the Europe’s strategy for international cooperation in research and innovation. The current strategy for international cooperation on research and innovation between Europe and the rest of the world was set out in a Commission Communication in
The European Joint Programme on Rare Diseases has launched its first academic education course “Diagnosing Rare Diseases: from the Clinic to Research and back” related to diagnosis in the rare disease’s context. The course, started on April 26th, will last 5 weeks with 3 hours weekly study. In 2019 the EJP RD has launched a
We are happy to inform you that the article "Diagnosis and Treatment of Chronic Neuropathic and Mixed Pain in Children and Adolescents: Results of a Survey Study amongst Practitioners" has been published in Children open access journal. The article shows the results of a questionnaire administrated to investigate the international practice amongst practitioners for the
The VISION-DMD published a white paper on how to return individual clinical trial results back to patients. It focuses on addressing the ethical and technical challenges, using the vamorolone clinical trial experience. The VISION-DMD is a project aimed to advance and accelerate the clinical development of the orphan drug vamorolone (also known as VBP15) for
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