Results 111 to 120 of about 57,098 (267)

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

British 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

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

The SCAPE preservation lifecycle [PDF]

IEEE/ACM Joint Conference on Digital Libraries, 2014
Kresimir Duretec, Artur Kulmukhametov, Michael Kraxner, Markus Plangg, Christoph Becker 0001, Luis Faria   +5 more
openaire   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 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

The impact of the current student loans regime on Muslim student engagement and retention in English higher education

British Educational Research Journal, EarlyView.
Abstract There is much interest in the potential for an alternative funding system for higher education students in England to support the spiritual and worldly needs of British Muslim students. At the heart of this issue lies a tension over whether the student financing system in English HE is haram, or forbidden under Islamic (Shari'ah) law, because ...
Richard Hall, Yusraa Maryam, Sumeya Loonat   +2 more
wiley   +1 more source

Addressing racialised awarding gap in higher education: Insights from personal tutors

British Educational Research Journal, EarlyView.
Abstract Situated within a wider cross‐institutional research project, this article provides an in‐depth case study of one higher education (HE) institution, focusing on how personal tutors make sense of racialised degree awarding disparities for both undergraduate and postgraduate students, how they perceive their responsibilities, the challenges and ...
Benjamin Ajibade, Rick Hayman, Angela Hibbs, Josephine Gabi   +3 more
wiley   +1 more source

The HALO Model: A Learning Health System Framework for Artificial Intelligence. [PDF]

Learn Health Syst
Zai AH, Adibuzzaman M, McManus DD, Walkey A.   +3 more
europepmc   +1 more source

Otherwise engaged? Learning from non‐participation in research with care‐experienced students

British Educational Research Journal, EarlyView.
Abstract This paper explores what can be learned when educational research “fails.” Drawing on a Welland Trust–funded project in the North East of England that aimed to support care‐experienced students transitioning from further to higher education, we reflect on why, despite sustained effort, there was a lack of engagement.
Lynette Harland Shotton, Tom Disney, Andrea Carrick, Laura Thurman   +3 more
wiley   +1 more source

A Structured Comparison of the Coalition for Health AI Responsible AI Guide and South Korea's Trustworthy AI Guideline for Health Care AI Assurance: Comparative Framework Analysis. [PDF]

JMIR AI
Vigeant T, Tam A, Shi Q, Allison J, Kim M, Sim JA, Won DO, Shin D, McManus DM, Lee JJ, Yu JY, Zai AH.   +11 more
europepmc   +1 more source