EGPAF

Accelerating Access to Optimal Child-Friendly Antiretroviral Formulations for Children Living with HIV: Lessons Learned from Eight Sub-Saharan African Countries

EGPAF, with funding and support from Unitaid and DNDi, is bringing new-to-market pediatric ARV formulations to full-scale implementation in eight African countries. We gathered and documented lessons learned from these eight project countries to inform, streamline and accelerate the introduction and roll-out of new, child-friendly ARVs so that all children living with HIV have access to optimal, WHO-recommended treatment and care.

Site Monitoring Guidance and Checklists

Regular monitoring of POC EID implementation sites is crucial for ensuring the quality and efficacy of site-level operations throughout the project. Site monitoring visits will provide essential insights into site-level issues related to human resources, patient flow, platform functioning, end user performance, specimen transport, data, data quality, and capacity building needs of site level staff.

Author: EGPAF

Year: 2017

Post-Market Surveillance

Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. WHO has developed normative guidance on post-market surveillance of in vitro diagnostics, emphasizing the importance of both reactive post-market surveillance and proactive post-market surveillance activities.

Reactive post-market surveillance refers to activities undertaken after an issue has occurred related to the IVD test (e.g., complaint reporting/monitoring; end user quality control programs, etc.), whereas proactive post-market surveillance refers to scans for potential issues related to the IVD (e.g., pre- and/or post-distribution lot testing). Lot testing involves testing samples from a manufacturing lot to ensure performance meets an acceptable standard.

For additional information on post-market surveillance, including sample reporting forms, see http://www.who.int/diagnostics_laboratory/postmarket/en/