The Uppsala Monitoring Centre is proud to announce that the new version of VigiFlow has been launched. The system is now undergoing continuous updates to comply with the latest international standards of ICH E2B(R3) and to offer improved support for entering data of ADR and AEFI reports.
What is changing?
The first launch mainly supports the workflow around manual case intake, structuring of data of ADR case reports and recording of causality assessment results (options for WHO-UMC causality, WHO AEFI causality and Naranjo methods). Through the function of sharing case reports with the WHO Programme for International Drug Monitoring, the users who also have access to VigiLyze will have easier access to the tool which enables analysis of national data for safety issues with the support of global data.
In the upcoming months, additional features will be added such as support for direct reporting from patients, healthcare professionals, pharmaceutical industries and Public Health Programmes. Also, both the interface and the medical terminology (MedDRA*) will be available in English, French, Portuguese and Spanish.
When is it coming?
VigiFlow is used in more than 70 countries and the updates will be rolled out gradually. The UMC will contact each national pharmacovigilance centre (NC) to set up a time table to start using the new VigiFlow version based on the features and languages that are being used. The goal is to have all national centres using the new VigiFlow at the end of 2018.
Feel free to contact the UMC at email@example.com if you have any questions about the new VigiFlow.
*The Medical Dictionary for Regulatory Activities (MedDRA) is the default medical terminology implemented in the new VigiFlow version. National centers currently using WHO Adverse Reaction Terminology (WHO-ART) in VigiFlow will be contacted by UMC to convert their ICSR data to MedDRA.