An Introduction for Pharmacovigilance Managers - Core Concepts of Drug Safety

- Regulatory framework and EMA GVP modules - Management of side effects and signals - Benefit-risk assessment and risk management - Important pharmacovigilance documents - Interfaces with other departments and quality managementATTENTION NEW DATE. The seminar has been rescheduled from 7-8 to 8-9 October!This intensive two-day online course offers a concise yet comprehensive overview of all core elements of pharmacovigilance, including EU regulatory requirements and their practical implementation. It is ideal for professionals who need a clear, structured understanding of the full range of pharmacovigilance activities.LernzieleThis online course provides comprehensive knowledge on all the essentials of pharmacovigilance over two days. It equips participants with the necessary tools to confidently fulfil their responsibilities in the various aspects of pharmacovigilance.- The course will enable you to... - describe the mechanisms of pharmacovigilance in Europe. - classify information on adverse drug reactions including MedDRA coding. - properly assess the responsibilities of pharmacovigilance officers. - understand the significance of pharmacovigilance and risk management systems. - comply with risk assessment procedures.ZielgruppenThis course will be conducted in English.- This online course is designed for professionals who need a clear and compact overview of all key pharmacovigilance activities. It is suitable for those at an early stage of their drug safety career as well as for experts from related areas who wish to broaden or refresh their knowledge of the full pharmacovigilance system. It is particularly relevant for staff working in - drug safety, patient safety, pharmacovigilance, - quality management, clinical research, medical affairs and regulatory affairs, - as well as for graduates in medicine or life sciences who are moving into these functions.