The GVP Refresher - Established Principles and New Developments in Good Pharmacovigilance Practices

- GVP Modules I-XVI and Annexes - Pharmacovigilance system master file (PSMF) - Monitoring, documenting and evaluating adverse drug reactions - Quality and risk management - Audits and inspectionsThe Good Pharmacovigilance Practices (GVP) Modules published by the European Medicines Agency (EMA) are the key reference for pharmacovigilance practice in Europe. This two-day online course offers a comprehensive and practice-oriented refresher on established requirements, current updates, and recent developments across the GVP Modules.LernzieleThe Good Pharmacovigilance Practices Modules (GVP Modules), published and regularly updated by the European Medicines Agency (EMA), set out the standards and measures for the effective fulfilment of pharmacovigilance responsibilities and serve as a key reference for drug safety in Europe.- Refresh and expand your knowledge of GVP in this course and apply what you learn directly in practical workshops. The course covers a broad range of topics, from pharmacovigilance systems in general to key documents such as the PSMF and PSURs, as well as quality and risk management.- Each topic is discussed in direct relation to the relevant GVP Modules, ensuring that all modules, including annexes, are thoroughly covered.ZielgruppenThis course will be conducted in English.- This online course is designed for professionals in the pharmaceutical industry seeking reliable continuing professional development or a structured refresher in pharmacovigilance. It covers all GVP Modules, has a strong practical focus, and is primarily intended for PV Managers and experienced professionals working at the PV interface.- A basic understanding of pharmacovigilance and/or practical experience is required.