International Clinical Trials Day is held on 20 May each year since 2005 to commemorate the day that James Lind began his famous trial for the scurvy. The objective is to make this moment a focal point for international communication events, meetings, debates, and celebrations of clinical research. This year, in occasion of the event,
The Committee on Bioethics (DH-BIO) - Council of Europe released “DH-BIO Statement on human rights considerations relevant to the COVID-19 pandemic”, recalling the fundamental principles, based on the respect for human dignity and human rights, which must guide medical decisions and practices in the context of the current crisis. It does not focus specifically on
We are happy to announce the publication on the European Pharmaceutical Law Review, special issue on AI in the pharmaceutical field. Among authors are Annagrazia Altavilla, Viviana Giannuzzi, Annalisa Landi and Adriana Ceci, members of the TEDDY Working Group on Ethics. This article analyses the GDPR provisions with the aim to verify if paediatric peculiarities
In occasion of the 16th Meeting of the Committee on Bioethics (DH -BIO) held on 19-21 November 2019, the Strategic Action Plan on Human Rights and Technologies in Biomedicine has been adopted for the period 2020-2025. The vision and approach of the Strategic Action Plan are to protect human dignity and the human rights and
We are happy to announce that the article “Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model” was published on Clinical Pharmacology & Therapeutics Journal. The publication derives from the activities carried out by the Working Group 3 ‘Data Sources and Multi-source Studies’ of the European
We are happy to present you the last novelty on TEDDY identity and governance. A new statute, indeed, has been approved by its associated members, foreseeing novelties in TEDDY identity and governance. The first news is related to the mission, oriented towards an integrated work with subjects involved in paediatric drugs development processes and aimed
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 performing clinical studies in children. Enpr-EMA is governed by a coordinating group which sets the network's
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 technology-driven paediatric medicines development processes from drug discovery and early
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 new Co-fund action and provides its contribution in this programme intended to create a research and innovation
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 idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.