Results 221 to 230 of about 291,337 (275)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source

Activism as education in and through the youth climate justice movement

British Educational Research Journal, EarlyView.
Abstract Young people worldwide are increasingly participating in a global movement for climate justice, yet to date, little research has examined how youth climate justice activists conceive of and experience activism as education. The present study used in‐depth, semi‐structured interviews with 16 US climate justice activists (aged 15–17) to address ...
Carlie D. Trott
wiley   +1 more source

‘Let's talk about the weather’: The activist curriculum and global climate change education

British Educational Research Journal, EarlyView.
Abstract Activist movements have garnered significant global attention on a range of sustainability issues, often involving collectives of citizens coming together. Invoked is the idea of citizens informed to act, emerging not from a common‐sense understanding of everyday life, but rather from a deep political understanding of the world—one that is ...
Richard Pountney
wiley   +1 more source

AI voice journaling for future language teachers: A path to well‐being through reflective practices

British Educational Research Journal, EarlyView.
Abstract This study aimed to explore the perceived impact of using an AI‐powered voice journaling app in overcoming the challenges and stressors encountered by senior students enrolled in teaching practicum at an English Language Teaching Bachelor's programme.
Bora Demir, Duygu Özdemir
wiley   +1 more source

Unveiling student sentiment dynamics toward AI‐based education through statistical analysis and Monte Carlo simulation

British Educational Research Journal, EarlyView.
Abstract This study explores the multifaceted dynamics of student sentiment towards artificial intelligence (AI)‐based education by integrating sentiment analysis techniques with statistical methods, including Monte Carlo simulations and decision tree modelling, alongside qualitative grounded theory analysis.
Volkan Duran, Ercümend Ersanlı, Hurinur Çelik   +2 more
wiley   +1 more source

“The purpose of activism is to educate”: Young people's climate activism as and for education in the youth strike movement in England

British Educational Research Journal, EarlyView.
Abstract By skipping school for their cause, young climate strikers repeatedly demonstrated their priorities in 2019 and 2020. They regularly chose to sacrifice a day of their formal education in favour of collective action. This study asks what we can learn from the reflections of former youth strikers.
Loz J. Hennessy
wiley   +1 more source

Teacher confidence and student engagement with mental health and wellbeing lessons: Learning from an iterative curriculum intervention in schools

British Educational Research Journal, EarlyView.
Abstract The mental health and wellbeing of young people has received increasing attention in both research and the wider public discourse. There has been a marked rise in mental health conditions in young people, and the burden of care is increasingly transferred onto schools and teachers.
Thomas Godfrey‐Faussett, Naomi French, Abbie Simpkin, Julian Turner, Tracey Riseborough, Natalie Coles, Ian Thompson   +6 more
wiley   +1 more source

Paediatric developmental safety and the ICH E11A extrapolation of safety

British Journal of Clinical Pharmacology, EarlyView.
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Rebecca Racz, Sherbet Samuels, Dionna J. Green, Lynne P. Yao   +6 more
wiley   +1 more source

Effective methods for increasing levels of political self‐efficacy for girls and disadvantaged students in England

British Educational Research Journal, EarlyView.
Abstract This study addresses the gap in rigorous evaluation of inclusive Citizenship Education methods in reducing gender and socioeconomic inequalities in political self‐efficacy. This article tests the effectiveness of two pedagogical approaches: counter‐narratives and think‐pair‐share.
Bryony Hoskins, Khuyen Dinh, Christian Christrup Kjeldsen   +2 more
wiley   +1 more source