European Medicines Agency EudraVigilance and signal management information day
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 European Union (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, European Medicines Agency (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.