Results 211 to 220 of about 4,084,990 (256)

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

Twenty years of inhaler therapy: A nationwide drug utilization study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to map nationwide trends and prescribing patterns in inhaler use from 2004 to 2023. In light of evolving clinical guidelines and attention to the environmental impact of inhalers within recent years, we also examined variation in prescribing behaviour and patient‐level treatment choices. Methods Using nationwide health registries,
Katrine Bitsch Johansen   +5 more
wiley   +1 more source

CancerWatch: accelerating Europe's cancer intelligence. [PDF]

open access: yesActa Oncol
Backes C   +12 more
europepmc   +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

Defining a comprehensive set of value assessment criteria for funders of drug repurposing initiatives

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aims to develop a structured list of value assessment criteria for drug repurposing (DR) projects designed to support consistent, evidence‐informed decision‐making by funders. The assessment criteria were developed within the REMEDi4ALL project, a multi‐stakeholder Horizon Europe funded initiative to advance DR and were validated ...
Dalma Hosszú   +10 more
wiley   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

open access: yes
British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera   +7 more
wiley   +1 more source

Young children's right to be heard on the quality of their education: Addressing potential misunderstandings in the context of early childhood education

open access: yesBritish Educational Research Journal, EarlyView.
Abstract In early childhood education many researchers and professionals across the world have embraced the United Nations Convention on the Rights of the Child's requirement to include young children in decision‐making. In the context of ongoing discussion about young children's capacity to share their views and opinions about matters affecting them ...
Laura Lundy   +3 more
wiley   +1 more source

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