Pharmacovigilance Signal Management - Detection, evaluation and data processing in line with GVP Module IX

- GVP Module IX inclusive expected updates: content and practical implementation - Implementing Regulation (EU) 2025/1466 - The signal management workflow based on selected PRAC case examples - EudraVigilance and EVDAS - Data analysis with R tidyverseIn this interactive two-day seminar, you will explore signal management best practices using PRAC case studies and learn how to effectively leverage digital tools such as EudraVigilance, programmable data analysis and AI. Complementary perspectives from both the marketing authorisation holder and the former authority provide valuable insights for your day-to-day work.LernzieleSignal management is a core component of pharmacovigilance and is among the most frequent critical findings during inspections. In this seminar, you will learn how to fulfil regulatory requirements while keeping your processes efficient and lean.- On the first day, the focus is on the regulatory fundamentals and the signal management process. Step by step, the process is worked through and discussed based on practical PRAC examples.- The second day covers advanced topics such as communication with authorities, the use of EudraVigilance, data-driven analyses, digital automation and the role of artificial intelligence in signal management.- A special highlight: Benefit from two complementary viewpoints: The marketing authorisation holder (MAH) perspective from global pharmacovigilance practice and the regulatory perspective from a former assessor.ZielgruppenThis course will be conducted in English.- This online seminar is designed for professionals in pharmaceutical companies who need to understand, implement and apply signal management in pharmacovigilance. The content is suitable both for experienced specialists and for those with initial professional experience.