New EudraVigilance System Goes Live

Recently we reported EMA to Launch New Version of EudraVigilance. On November 22, 2017, EMA reported that “The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.” Included in the full story are the “enhancements and expected benefits.” Contact us for help with your PSURs and PADERs.