To strengthen the implementation of the new EudraVigilance system, the system for managing and analyzing information on suspected adverse reactions to medicines in the EEA, the EMA has published a change management plan for stakeholders, including key dates and training modules.
According to the schedule, the EudraVigilance audit will take place in the first quarter of 2017, with audit results in May 2017, and the move to simplified reporting and the implementation of new EudraVigilance functionalities in November 2017.
To provide support during the implementation of the new EudraVigilance system, the Agency is developing training modules that will be presented during 2016 and 2017.
The first group of learning modules are already available via the EMA website.
– Marketing authorization holders need to begin training in new EudraVigilance functionalities, and are invited to give feedback about the e-learning modules. A link to the online survey is included with all training materials
– Stakeholders are recommended to develop detailed individual training plans internally, to manage their transition to the new system.
More info: EudraVigilance system