The Clinical Trials Europe is the Europe's largest event dedicated to streamlining clinical trials and improving patient outcomes. The 2020 Edition will take place virtually on 2-4 November due to covid-19 pandemic. The agenda will foresee 6 conference streams and 2 plenaries that will provide the occasion to bring together collaborative stakeholders, key associations dedicated
The Committee for Orphan Medicinal Product (COMP) of the European Medicines Agency (EMA) will organise a Workshop on support for orphan medicines development on 30 November 2020. The virtual event aims to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. Existing tools such as orphan
The XIII Foresight Training Course (FTC) will be held virtually on 23 October 2020. Annually, Fondazione Gianni Benzi organises the Foresight Training Course (FTC), a short international course aimed to promote pharmacological research and innovation. This year, due to the COVID-19 restrictions enforced, the XIII FTC will run virtually in a shorter version and will
EPTRI the new establishing European Research Infrastructure entirely dedicated to paediatric research and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), has successfully submitted the application to be included in the ESFRI Roadmap 2021, on the 9th of September. The inclusion of EPTRI in the Roadmap will be of great relevance as it will
Annagrazia ALTAVILLA, Chair of TEDDY, has been appointed as consultant/expert of the Council of Europe - Bioethics Division, within the new DH -BIO Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025). This plan provides specific considerations on children and paediatric population, underlining that important human rights challenges are also emerging through established
The European medicines regulatory network (EMRN) represents a unique response to the challenge of regulating human and veterinary medicines across a diverse group of countries. It includes the national competent authorities (NCAs) of the 27 EU Member States plus those of Iceland, Liechtenstein and Norway, and also come together under the aegis of the Heads
The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals
The European Medicines Agency (EMA) is preparing the guidance on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. TEDDY Network provided its contribution to the discussion paper, in particular stressing the importance to spend particular attention to the data
The Food and Drug Administration launched a docket to require inputs and comments from patients, patient advocates, the scientific community, health professionals, regulatory and health authorities and general public regarding practical steps to establish a rare diseases clinical trial network. Enpr-EMA response to the FDA’s request for information and comments on Rare Disease Clinical Trial
EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood