Impact of environmental factors on spontaneous reporting trends and safety signal detection in the EudraVigilance database

Changes brought to the ecosystem and geopolitical environment can have an effect on several fields including the healthcare system. Recently, we observed the impact that COVID-19 pandemic has had on the healthcare workers’ practices and people’s behaviour regarding their health status. Changes in spontaneous reporting trends were also observed. Lately, Europe has also witnessed the Brexit which is another important event that can influence spontaneous reporting practices knowing that the United Kingdom is an important source of spontaneous reports. In Europe, adverse drug reactions (ADRs) suspected to be caused by authorized medicine can be reported to a publicly available pharmacovigilance system called EudraVigilance. This project aims at determining the impact of different environmental factors such as geopolitical changes (Brexit) and sanitary situations (COVID-19) on spontaneous reporting trends and practices from the EudraVigilance database. A context without the occurrence of these events will be simulated to develop a use case and assess if changes in reporting could have caused a loss in safety signal detection.

Faculty Supervisor:

Anick Bérard

Student:

Partner:

Yola Rx Consultants

Discipline:

Life Sciences

Sector:

Manufacturing; Professional, scientific and technical services

University:

Université de Montréal

Program: