EudraVigilance information day
Location: European Medicines Agency, London, UK
This EudraVigilance Information Day provides a forum to prepare stakeholders for the implementation and launch of the new EudraVigilance system in the context of the pharmacovigilance legislation and to facilitate change management as part of the Agency's pharmacovigilance programme. The focus of this Information Day will be on providing a project update and an overview of the Agency's preparations to launch the new EudraVigilance System including various stakeholder support initiatives. The Information Day will also serve as a platform to experts of medicines regulatory authorities and marketing authorisation holders to share their change management planning experience and to raise specific process related or technical questions. Updates of the work of the ICH E2B Implementation Working Group, which is coordinating the implementation of the ICH E2B (R3) ICSR format at international level, will be also provided.