The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the protection of public health in the European Union (EU).
EMA will launch a new and improved version of EudraVigilance on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
The Agency is delivering training courses on the enhanced EudraVigilance system to support national competent authorities (NCAs) and marketing authorisation holders (MAHs) in the European Economic Area (EEA). Training includes targeted e-learning and face-to-face trainings, webinars and information days.
EMA strongly recommends that both new and existing users complete all EudraVigilance and pharmacovigilance trainings recommended for their stakeholder group, as both the EudraVigilance system and pharmacovigilance guidelines are subject to updates.
In order to help users prepare for the changes resulting from the enhanced EudraVigilance system, EMA has developed a modular training curriculum