Results 81 to 90 of about 7,527 (257)

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Institutional Accreditation and Its Impact on Children’s Health in Orphanages: A Systematic Literature Review on Learning Organizations and Quality Assurance

open access: yesSocial Sciences
The process of institutional accreditation establishes crucial mechanisms that lead to better quality childcare in orphanages through the development of organizational stability and trained staff, in addition to healthcare improvements. The assessment of
Dewi Kartikawati   +3 more
doaj   +1 more source

Cultural Erasure: The Absorption and Forced Conversion of Armenian Women and Children, 1915-1916

open access: yesÉtudes Arméniennes Contemporaines, 2016
Religious conversion and forced assimilation of Armenian women and children into Muslim households were two of the most significant structural components of the 1915 Armenian Genocide. In other words, Islamization of Armenian women and children – as well
Ümit Kurt
doaj   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden   +3 more
wiley   +1 more source

Making space and community through memory:

open access: yesÉtudes Arméniennes Contemporaines, 2017
This article aims to discuss the making of space and community in the Armenian quarter of Jerusalem, by introducing a collection of photographs from the AGBU Nubar Library in Paris, which were gathered and archived in the 1920s and 1930s.
Boris Adjemian, Talin Suciyan
doaj   +1 more source

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

open access: yesBritish 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   +5 more
wiley   +1 more source

“The British coloureds of Sophiatown”: The case of St. Joseph’s Home for coloured children, 1923-1998

open access: yesContree, 2017
During apartheid South Africa (1948-1994), black, coloured, and Indian children did not enjoy the same privileges as their peers of European descent – because of racial discrimination.
Charmaine T. Hlongwane
doaj   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer   +4 more
wiley   +1 more source

With One Eye Closed: Illegal orphanages in rural China [PDF]

open access: yes, 2019
This article considers the state’s response to unregistered and unregulated orphanages in China. The author concludes that for these orphanages, legality is generally neither here nor there, until an accident or scandal occurs and the orphanage is ...
High, Anna
core  

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis   +4 more
wiley   +1 more source

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