The backbone of medicines and vaccines safety monitoring
Even after a medicine or vaccine is approved, we need to be sure they stay safe. With VigiFlow as their national pharmacovigilance database, regulatory authorities can monitor the safety of medicines and vaccines in their own countries and share information globally.
Reducing the likelihood of adverse events being repeated
Every day national pharmacovigilance centres around the world rely on our solutions for collecting and analysing adverse event data.
VigiFlow is a web-based system for managing adverse event reports that incorporates standardised medical terminologies such as WHODrug Global and MedDRA.
- Workflow support aligned to your pharmacovigilance processes helps you optimise collection, triage and assessment of reports.
- Allocate workloads by delegating reports to pharmacovigilance units in your network.
- Built-in WHODrug Global and MedDRA coding support.
Using VigiFlow eForms, national centres can collect information on side effects to medicines and vaccines from patients, health workers and industry digitally. Depending on a country's national surveillance system setup, workflows can be configured to automatically route reports to regional or district authorities, streamlining workload distribution.
Without VigiFlow the advances we have made in increasing patient reporting, sharing reports with VigiBase and fully incorporating ICH guidelines would not have been possible in such a short time and at such a low cost.
Marcelo Vogler de Moraes (Former) Manager of Pharmacovigilance, Brazilian Health Regulatory Agency (Anvisa)
Our digital reporting forms for patients and health workers boost the quality and quantity of data national centres receive by making it easier for reporters to collect information on suspected side effects to medicines and vaccines.
VigiFlow eReporting for Industry
Regulatory reporting made easy for marketing authorisation holders, with built-in drug and adverse event coding for fully ICH-compliant clinical trial and post-marketing safety data.
VigiFlow makes it easier for different stakeholders to exchange safety information in a range of formats, including Excel, xml/ICH E2B. It also offers secure, controlled and convenient sharing of adverse event reports to VigiBase, the WHO global database of adverse event reports, the EMA's EudraVigilance database and other systems, such as DHIS2 and the WEB-RADR Vigilance Hub.
VigiFlow is essential for securing the safety of medicines and vaccines. It allows national centres to rapidly identify potential safety concerns associated with medicines or vaccines and to take appropriate regulatory action to reduce the likelihood of the side effect recurring.
VigiFlow gives national centres control over their critical pharmacovigilance processes while guaranteeing the integrity of their data. Secure and controlled data management means no installation, backups or maintenance for countries. We take care of all of that.
- VigiFlow is an easy-to-use, web-based platform requiring minimal training or customisation.
- Data is accessible only to authorised users. You set permissions to determine the information users can see and the actions they are allowed to perform.
- UMC charges a licence fee for VigiFlow determined by the World Bank Atlas method.
We rely on these tools to eliminate reporting barriers and generate more information of a high enough quality for signal detection.
María Antonieta Gamarra General Director of the Dirección Nacional de Vigilancia Sanitaria, Paraguay’s national regulatory authority.