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 (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19....
The European Medicine Agency (EMA) is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students, who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose...
The Innovative Medicines Initiative has launched IMI2 – Call 23. IMI2 – Call 23 is a standard, two-stage Call for proposals with the following topics: Returning clinical trial data to study participants within a GDPR compliant and approved framework Modelling the...
Food and Drug Administration (FDA) is developing four guidance documents to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information...
The European Commission is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry, addressing mainly: the life cycle of medicines from R&D to authorisation...
Data collection in healthcare allows health systems to create holistic views of patients, personalize treatments, advance treatment methods, improve communication between doctors and patients, and enhance health outcomes. For this reason, the promotion of data...
The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could...
Encouraging active participation and self-determination of patients and parents in the caring procedure, and promoting their involvement in scientific research and drug development process is the main objective of TEDDY Working Group on “Active engagement of children...
We are pleased to inform you that the article “Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance” has been published on the European Journal of Health Law. The authors, Annagrazia Altavilla, Viviana...