Results 211 to 220 of about 2,076,500 (256)

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

open access: yesBritish 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   +19 more
wiley   +1 more source

Peritoneal exosomes mediate activation of CD4<sup>+</sup> T cells and enhancement of vaccine efficacy in teleost. [PDF]

open access: yesCell Commun Signal
Shi X   +10 more
europepmc   +1 more source

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

The impact of medication shortages on paediatric care: A retrospective impact analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg   +6 more
wiley   +1 more source

Type I interferon restricts mRNA vaccine efficacy through suppression of antigen uptake in cDCs. [PDF]

open access: yesNPJ Vaccines
Lobb TA   +9 more
europepmc   +1 more source

Health economic considerations for pharmacogenomic services in the United Kingdom: The Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics

open access: yes
British Journal of Clinical Pharmacology, EarlyView.
Dyfrig A. Hughes   +4 more
wiley   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke   +7 more
wiley   +1 more source

Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.

open access: yesBiologicals
de Moerlooze L   +24 more
europepmc   +1 more source

Home - About - Disclaimer - Privacy