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...
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...
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,...
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...
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...
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...
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...
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...
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...
U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their...