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The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers. The guideline is available at this link. Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for

EPTRI (European Paediatric Translational Research Infrastructure), the European project funded within H2020 Infradev-01-2017 call for proposals and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) reached the end of its exciting journey, which allowed setting the basis for a new important step. The two-years funded project has come to an end, by the preparation

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 discussion paper, in particular stressing the importance to spend particular attention to the data

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. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of

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 of a traineeship at the Agency is to perform tasks that are predominantly

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 from patients and caregivers for medical product development and regulatory decision making. The first document is dedicated to Patient-focused

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 impact of monoclonal antibodies and vaccines on the reduction of antimicrobial resistance (part of

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 would like to gather input from patients, consumers and healthcare professionals as data

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 30% teaching activities, offering a mix of responsibilities, such as: conducting research into development and evaluation of methods to generate evidence

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 advisable. Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)