Results 141 to 150 of about 644 (200)

Project subpage on corporate website

D 5.1: Project subpage on corporate website [M3], Deliverable type ...
openaire   +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

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

Website, Corporate Design and Templates

This short deliverable will define the design, the final logo, the colour scheme and other elements that build the basis for the EXCELLERAT brand. This will feed into the web site which will start in M1 of the project and which is updated at the latest in M3 based on the chosen logo and colour schemes.
openaire   +1 more source

S. aureus colonization and clinical symptoms remain stable upon topical XZ.700 treatment: Results of a double‐blind randomized clinical trial in patients with mild to moderate atopic dermatitis

British Journal of Clinical Pharmacology, EarlyView.
Aim Recovering dysbiosis may improve atopic dermatitis (AD) symptoms. XZ.700 is a recombinant chimeric endolysin that specifically targets Staphylococcus aureus and could be a new treatment option for patients with AD. The aim of this first‐in‐human study was to evaluate the safety, tolerability and efficacy of topical XZ.700 and explore the ...
Laura W. J. van der Meulen, Menthe E. Bergmans, Salma Assil, Naomi Klarenbeek, Marieke L. de Kam, Alexa J. Tibboel, Thorsten Brach, Bjorn L. Herpers, Johan Frieling, Vincent de Jong, Benthe Freyee, Martijn B. A. van Doorn, Robert Rissmann, Tessa Niemeyer–van der Kolk   +13 more
wiley   +1 more source

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

British Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson, Helen Dolk, Maria Loane, Christine Damase‐Michel, Joanne Given, Hedvig Nordeng, Jorieke E. H. Bergman, Iain Carey, Elly Den Hond, Ester Garne, Florence Rouget, Lea Bruneau, Isabelle Monier, Anke Rissmann, Mary O'Mahony, Miriam Gatt, Renée Lutke, Joanna Sichitiu, Elisa Ballardini, Alessio Coi, Clara Cavero Carbonell, David Tucker, Joan Morris   +22 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

British Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus, Johaina Sarrage, Hilde Samdal, François Montastruc, Elena Rocca   +4 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Mobile health interventions to improve adherence to oral anticoagulant treatment: A systematic review and critical analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Non‐adherence to oral anticoagulants (OACs) is associated with significant morbidity and mortality. Mobile health (mHealth) interventions have been used to improve medication adherence across the three phases of initiation, implementation and persistence.
Non Davies, Elin Haf Davies, Dyfrig A. Hughes   +2 more
wiley   +1 more source

Framing National Education in Hong Kong: A frame analysis of power dynamics in stakeholders' competing narratives

British Educational Research Journal, EarlyView.
Abstract This article examines how national education in Hong Kong functions as a contested arena in which state and non‐state actors struggle over the meaning of citizenship, identity and schooling. Using inductive frame analysis of 319 news articles (2020–2025) from five Chinese‐ and English‐language outlets, it identifies diagnostic, prognostic and ...
Jason Cong Lin
wiley   +1 more source

Publicly funded private schools and academic achievement: A comparative analysis of PISA data in European countries

British Educational Research Journal, EarlyView.
Abstract This paper analyses differences in academic achievement associated with attendance at publicly funded private schools and public schools across 11 European countries. Using eight waves of PISA data (2000–2022), we apply OLS, IPW and IPWRA estimators to account for observed heterogeneity and mitigate selection bias.
Priya Maurya, Léonard Moulin, Denis Fougère   +2 more
wiley   +1 more source