Pharmacovigilance Signal Management Fundamentals

• Understand key definitions, sources, and the lifecycle of pharmacovigilance signals 
• Explore detection methods, including statistical and clinical approaches, with real-world examples 
• Learn how to assess benefit-risk and apply regulatory frameworks from EMA, FDA, and WHO 
• Gain practical insight into signal tracking tools, documentation, and global reporting timelines

This training provides a comprehensive introduction to signal management in pharmacovigilance. Participants will explore the key definitions and regul- atory expectations surrounding safety signals, from hypothesis generation to validation, assessment, and communi- cation. The course covers practical aspects of signal detection in both spontaneous and clinical trial data, highlights common pitfalls, and com- pares qualitative and quantitative detection methods. It introduces core regulatory frameworks and tools used in signal tracking, assessment, and reporting, while emphasizing the importance of scientific rigor in benefit- risk evaluation. Case examples and real- world scenarios will help participants understand how to apply regulatory requirements (EU, FDA, WHO) in day- to-day practice. This seminar is ideal for professionals seeking foundational knowledge in signal management and aims to strengthen their ability to contribute to patient safety in a global regulatory context.