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...
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 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...
The European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” 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. Therefore, EMA...
The Department of Pharmaceutical Sciences, Pharmacoepidemiology and Clinical Pharmacology of Utrecht University shared a vacancy announcement for Tenure track Assistant Professor position in Real World Evidence. The full-time position involves 70% research time and...
The U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not...
EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes...
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...
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...
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...