This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore "out ... Read more
The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps create a shared understanding of intended scientific decisions through core recommendations for clear and reproducible RWE study protocols. Pilot testing plans are underway. Read more
Renewed partnership will broaden the scope of SPEAC to deliver world-leading vaccine safety guidance & support for CEPI’s mission to compress development of new vaccines against pathogens with pandemic potential to 100 days Read more
Recommendations include: creating a culture where PV is prioritised, engagement / empowerment of communities to report harms, systems / infrastructural development, & learning within / between countries Read more
The importance of systematically involving patients from early development through regulatory process to ongoing monitoring and safe use in everyday healthcare. Read more
A collection of videos from experts in the field of Data Monitoring Committees Read more
Open access paper reviewing changes in safety surveillance, recent scientific advances, & arguing how they need to be harnessed to enhance pharmacovigilance Read more
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This module from the Toolkit for research and development of paediatric antiretroviral drugs and formulations introduces the concepts of pharmacovigilance and adverse drug reactions, discusses the burden of adverse drug reactions for children and explains the importance of pharmacovigilance in the context of antiretroviral therapy.
The problem of substandard and falsified (SF) medical products affects all countries but few regulatory authorities or pharmaceutical companies have policies of publicly releasing data. In order to fill the ...