A mine of information on potential safety risks
When issues with regulated products arise, you want to know about them. Timely reporting by consumers, healthcare workers and regulated pharmaceutical companies allows you to act quickly for patients' well-being.
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Reducing the likelihood of adverse events being repeated
Every day, pharmacovigilance professionals around the world use our solutions to support the collection, processing and analysis of adverse event reports that are critical for a national pharmacovigilance system to function properly. VigiFlow was developed for and by national regulatory agencies to strengthen post-marketing surveillance.
VigiFlow is a cloud-based pharmacovigilance management system with streamlined easy-to-follow workflows that uses integrated standardised medical terminologies such as WHODrug Global and MedDRA.
- Workflow support aligned to your pharmacovigilance processes helps you optimise collection, triage, and assessment of cases.
- Allocate workloads by delegating cases to pharmacovigilance units in your network.
- Built-in WHODrug Global and MedDRA coding support.
Through the eReporting module, national centres can collect side effects to medicines and vaccines from consumers, healthcare workers, and regulated pharmaceutical companies. eReporting allows the consumer, or healthcare worker, to create, review and report side effects via their smartphone or other device from anywhere with internet access. The reported side effects will be instantly available as adverse event reports in VigiFlow for further processing.
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 Manager of Pharmacovigilance, Brazilian Health Regulatory Agency (Anvisa)
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VigiFlow supports data exchange of safety information with internal and external stakeholders in different formats such as Excel, xml/ICH E2B. VigiFlow provides secure, controlled, and easy sharing of adverse event reports to WHO through VigiBase, WHO’s global database of reported potential side effects of medicinal products, EMA (EudraVigilance) and other systems such as DHIS2 and Vigilance Hub.
VigiFlow is essential for securing the safety of medicines and vaccines. It allows national centres to rapidly identify any potential safety concerns associated with medicines or vaccines and to take appropriate regulatory action to address these issues, thereby reducing the likelihood of the side effect being repeated.
VigiFlow gives you control over your critical pharmacovigilance processes while guaranteeing the safety of your data. Secure and controlled data management means no installation, back-ups, or maintenance is required. It is all covered by our services.
- VigiFlow is an easy-to-use, cloud-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.