VigiFlow

VigiFlow is a pharmacovigilance data collection platform developed by UMC (Uppsala Monitoring Centre) that consolidates safety data from multiple reporters into a single, unified national database. It is designed for national regulatory authorities, pharmacovigilance staff, health workers, marketing authorisation holders, and the general public, supporting the identification of rare and previously unknown adverse effects of medicines and vaccines.

Because rare side effects may not emerge until a medicine or vaccine has been used by large numbers of people, efficient data collection across multiple channels is essential. VigiFlow addresses this by providing structured data capture tools that improve accuracy, reduce errors and inconsistencies, and speed up analysis and decision-making.

Key Features

• Connected web and mobile applications allow health workers and the public to report adverse events for medicines and vaccines, streamlining data collection and analysis.
• A desktop data entry form enables pharmacovigilance staff to manually enter reports received via email, phone, or paper.
• An industry e-reporting module allows marketing authorisation holders to submit ICH E2B-compliant XML files or enter reports manually, with built-in coding to MedDRA and UMC's Drug Dictionary, WHODrug Global.
• VigiFlow can receive safety data from any system that supports the ICH E2B standard, including ODK Collect and the Med Safety app.

Structured Data Capture Applications

• VigiMobile provides customisable templates for reporting adverse events for medicines and vaccines, including forms that capture the core variables recommended by WHO.
• VigiFlow eReporting for Industry is available as an add-on to collect safety data from marketing authorisation holders in line with ICH guidelines, supporting both manual data entry and ICH E2B-compliant XML submissions.
• Built-in coding to MedDRA and WHODrug Global within the industry module helps reporters comply with national regulatory requirements.

Interoperability

• VigiFlow uses the ICH E2B standard to integrate data from a variety of external sources and systems.
• It is compatible with third-party data collection tools that support ICH E2B, such as ODK Collect and the Med Safety app.
• Data collected through VigiFlow can be shared with VigiBase, UMC's global database of individual case safety reports.

VigiFlow is part of the broader Vigiverse ecosystem of UMC tools and services. Its adoption has been noted by national regulatory authorities including Brazil's Anvisa and Botswana's BoMRA, the latter of which uses VigiFlow and connected applications to reduce underreporting at a national level.