EudraVigilance is a cornerstone for the conduct of pharmacovigilance in the EU. The new EudraVigilance system, which was subject to an independent audit in 2017, is now operational for almost one year. Based on the anniversary, this Information Day will provide a platform to exchange operational experience in using the new system functionalities and applying the simplified adverse reaction reporting rules. As regards signal management using EudraVigilance, a phased approach in the EU was agreed in the form of a pilot, which started in February 2018 involving a limited number of active substances selected based on the list of medicinal products subject to additional monitoring. In August this year, EMA announced the extension of the pilot beyond February 2019 to allow for additional experience to be gained. As part of a dedicated signal management session, pragmatic approaches and lessons learned so far will be discussed at this Information Day. The event will conclude with an outlook of current and future challenges in pharmacovigilance focusing on the impact of the coming into force of the General Data Protection (GDPR) Regulation in May 2018, the latest developments as regards MedDRA and a proposed pharmacovigilance vision for the next years to come.