Despite progress of pharmacological research in the paediatric field, the problem of the availability of medicines for children has still not been solved and it is more evident in newborns, because some issues related to clinical trials are even more highlighted.
Clinical data reuse for research purposes is relevant to address the unmet clinical needs, but at the same time, secondary use of personal data is particularly challenging, especially in the case of research involving vulnerable populations, such as children.
EMA has recently published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases.
EURORDIS has organised the EURORDIS Photo Award 2020 that is an opportunity to visually express what it means to live with a rare disease and to share patients’ stories with the rare disease community and beyond.
The European Medicines Agency (EMA) published an interactive timeline describing the journey of a medicine authorised by EMA through the EU centralised procedure.
Gianni Benzi Foundation is member of TEDDY the European Network of Excellence for Paediatric Clinical Research that aims to enhance clinical research and paediatric medicines availability.
Puglia, through ARTI – Agenzia Regionale per la Tecnologia e l’Innovazione (Innovation and Technology Regional Agency) with the intervention “Estrazione dei Talenti”, will finance projects involved with the enterprise creation addressed to aspiring innovative entrepreneurs Team.
In order to support and accelerate the research, data should be shared and disseminated, but at the same time the privacy right of the subjects should be safeguarded, considering data protection obligations.
Fondazione Gianni Benzi participated to the EMA consultation on methodological and operational considerations in the use of patient disease registries for regulatory purposes.
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).
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