Results 221 to 230 of about 3,515,684 (279)

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

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

Pharmacogenomics of dolutegravir: A scoping review of evidence, gaps and clinical implications

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Dolutegravir underpins modern first‐ and second‐line HIV treatment regimens; however, interindividual variability in its disposition and tolerability presents challenges for optimal use. This scoping review mapped current evidence on the pharmacogenomics of dolutegravir, focusing on pharmacokinetics and pharmacodynamics, and methodological limitations ...
Ronald Kiguba   +2 more
wiley   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail   +4 more
wiley   +1 more source

Navigating Scientific Inquiry in East Africa Amidst Declining Research Funding. [PDF]

open access: yesEast Afr Health Res J
Wandiga S   +3 more
europepmc   +1 more source
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ICT4Governance in East Africa

2015
There is growing interest and increasing investment in the role of Information and Communication Technologies (ICTs) in governance across Africa, however, empirical evidence on the use of ICTs in governance in East Africa remains scanty. The ICT for Governance study in East Africa is a study investigating how ICTs are being used in four specific areas ...
Varyanne Sika, Nanjira Sambuli
openaire   +2 more sources

Three Decades of Land Cover Change in East Africa

Land, 2021
Zhiqiang Yang   +2 more
exaly  

Future Changes in Precipitation Extremes over East Africa Based on CMIP6 Models

Water (Switzerland), 2021
Hassen Babaousmail   +2 more
exaly  

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