The European Medicines Agency (EMA) has published an updated question and answer (Q&A) document from stakeholders on the launch of the new EudraVigilance system. The document addresses questions that were received from stakeholders as part of the launch of the new EudraVigilance system, which went live on 22nd November 2017.
The Q&A document answers questions that were received through the Agency’s service desk and the EudraVigilance technical and pharmacovigilance support webinars that were organised by the EMA. Sections in the Q&A document include: EudraVigilance organisation and user registration; use of EVWEB and the Individual Case Safety Report (ICSR) download manager; medical literature monitoring; reporting to National Competent Authorities in the European Economic Area (EEA) and technical questions.
The EMA states that the document will be regularly updated and should be consulted as a first reference source before contacting the Agency’s service desk.
To view the Q&A document from stakeholders on the launch of the new EudraVigilance system, please click here.