Good Pharmacovigilance is based on reliable information leading to an effective assessment of the risk-benefit balance which is crucial both in the clinical development and post-marketing safety of medicines. Therefore, understanding the latest regulations and innovation is essential. Pharmacovigilance has radically changed over the last few years, the ever changing global and local regulatory demands have put a lot of stress on the pharmaceutical, biotech companies and all stakeholders involved. Now more than ever companies are looking for effective tools to meet the increasing regulatory demands and harmonize PV activities. This premier event aims to give all stakeholders in Pharmacovigilance a better understanding on how to better manage drug safety across all departments.