This course presents the regulatory environment for the pharmaceuticals industry along with numerous directives, regulations and guidelines. During this  2-day course you will have the opportunity to learn pharmacovigilance working on case studies. At the end of the course you will produce practical advice and develop adequate strategies to handle reporting requirements.You will learn how collect and report adverse events and safety data and manage the risk associated with risk to your products. This unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.WHAT YOU WILL LEARNHow to effectively monitor your drug safety profile and avoid inspection findingsRisk and post-marketing issues that can negatively impact your drug sales revenueRecognising key signals over time and take corrective and preventive actionEU requirements: Directives, regulations and guidelinesCompiling and presenting key information to reduce errors of interpretationPrepare PSURs or PBRERS – when and how to changeWHO SHOULD ATTENDHeads, Directors, Senior Managers and Managers of:Pharmacovigilance, Pharmacology, Pharmacoepidemiology, Risk Management, Drug Safety, Signal Detection, Data Mining, Benefit/Risk Assessment, QPPV, Medical Affairs, Medical Information, Regulatory Affairs, R&D, Clinical Safety, Quality Assurance, Inspections, Audits, PSMF