With the promise to be the biggest change to the regulation of human medicines since mid-1990’s, the European Union has redefined the practice of Pharmacovigilance by new legislation taking effect from July 2012. By managing risk proactively, avoiding administrative burdens, and providing for a greater connection between safety assessments and regulatory action, the new set of rules aims for improved public health in general and greater patient safety in particular.Following up on two very successful events in January 2011 & 2012, Fleming Europe is proud to introduce to you the 3rd Annual Pharmacovigilance & Risk Management Strategies conference. This 2-day event will bring together expert minds from the industry, regulatory authorities and government to examine the Pharmacovigilance areas of key concern:Recent developments and insights into new features and key changes introduced by the new PV legislation and its implementation (RMPs, safety reporting, PASS/PAES, etc.)Overview and implications of the ICH E2C (R2) guidelinePV developments outside the ICH regionCreation of a successful and cost-effective PV system in the frame of the new legislationCreation of safety data exchange agreementsEffectiveness of risk minimisation and establish monitoring systemPV in special products & populations (vaccines & elderly)