Results 151 to 160 of about 4,025,963 (296)

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish 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   +2 more
wiley   +1 more source

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end‐point was submission type.
Andrea Manfrin   +7 more
wiley   +1 more source

University strategy in transnational higher education: The strategic approaches of newly established and ‘small’ international branch campuses

open access: yesBritish Educational Research Journal, EarlyView.
Abstract Newly established international branch campuses (IBCs) commence operations without a student body, and even after several years, many institutions fail to grow beyond 500 students. Despite having unique strategic needs, small IBCs are largely overlooked in the higher education literature.
Stephen Wilkins, Joe Hazzam
wiley   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

open access: yesBiotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga   +2 more
wiley   +1 more source

Integrating a Fragmented Pharmacy Network into a Unified Supply Chain System: A Case Study from Qatar's Primary Healthcare. [PDF]

open access: yesJ Healthc Leadersh
Al-Zaidan M   +6 more
europepmc   +1 more source

What drives animal responses to high severity fire? The role of functional traits

open access: yesBiological Reviews, EarlyView.
ABSTRACT Fire regimes are changing worldwide, with increases in the frequency, extent, and severity of fires posing growing risks to biodiversity. Fire severity – the degree of habitat alteration following fire – strongly influences both immediate survival and long‐term recovery of fauna.
Grace A. Vielleux   +3 more
wiley   +1 more source

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