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Philippines Uses PViMS App to Roll out Groundbreaking Tuberculosis Drug

The Philippines has one of the highest TB burdens in the world—and 2.6% of its more than 286,000 new cases in 2015 were of multi-drug-resistant TB (MDR-TB). This threatens the progress the country has made in addressing the deadly disease over the past few decades and its goal to make the country TB-free by 2030. […]

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Pharmacovigilance Monitoring System (PViMS) User Guide

The user guide primarily serves as a reference in reporting an adverse event (AE) through PViMS. It also serves to guide reporters and investigators in completing a correct and accurate AE report. This guide outlines the key data needed, starting from the initial alert to the completion of an AE report in PViMS.

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Pharmacovigilance Monitoring System Readiness Assessment, Philippine Department of Health

SIAPS, in partnership with the FDA, NTP, and LCP-NCPR, conducted a readiness assessment to determine the current information technology (IT) infrastructure, human resources, processes, and data management and quality control mechanisms available and to identify gaps in the current PV recording and reporting of patients in the seven Programmatic Management of Drug-Resistant TB (PMDT) treatment facilities implementing the 9MTR for multidrug-resistant (MDR)-TB study. The results of this assessment will provide inputs for developing the PViMS implementation plan.

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Bedaquiline Treatment Reaches 200 Patients in Georgia

Georgia is one of the first countries to benefit from the USAID‑Janssen Therapeutics bedaquiline (BDQ) donation program. Along with delamanid, BDQ is one of only two new TB medicines released to the market in over 40 years. These medicines are being used for the treatment of MDR-TB patients, as well as TB patients who have […]

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PViMS

An integrated approach to monitoring the safety of medicines that includes both active surveillance and spontaneous reporting is essential to a well-functioning pharmaceutical sector. Active surveillance is particularly important to support the introduction of new essential medicines in low-and middle-income countries, where regulatory systems are often still developing and need support. In such resource-limited settings, […]

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