This short course will provide a forum to discuss the experience gained with the launch of the new EudraVigilance system, the simplified ADR reporting and access principles as well as the application of the provisions set out in Good Pharmacovigilance Practice Module VI, for which revision 2 was published in the 3rd quarter of 2017. The course will also address highlights of the signal management pilot, which was initiated in February 2018.

The course will provide an update on the initial implementation experience, discuss practical examples, address frequently asked questions and next steps.