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...
EC online stakeholder survey into the use and re-use of health data in the light of the General Data Protection Regulation
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...
Vacancy Announcement. Utrecht University: Tenure track Assistant Professor position in Real World Evidence
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...
FDA Approves Dupilumab For Children With Atopic Dermatitis
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 New medicine authorised: gene therapy Zolgensma for the treatment of spinal muscular atrophy
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...
TEDDY Publication. Ethical, legal and regulatory issues of paediatric translational research call for an adequate model of governance. European Journal of Health Law. May 2020.
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...
TEDDY WG on patients’ engagement intends to launch a call for participants to the TEDDY Kids advocacy group
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...
TEDDY WG on off-label use. Updating of list of medicines used off label in 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...
TEDDY WG on health data. Revision and analysis of Post-Authorisation studies in paediatric population included in the EU PAS Register
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...
Pharmaceuticals – safe and affordable medicines (new EU strategy)
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...