Signal Management: CTs and Post-Marketing

Ensuring PV Compliance Through Effective Audit Strategies 

• Signal management procedure: Identify, assess and document safety signals, ensuring review, escalation and risk mitigation 
• Signal management in clinical trials: Ongoing monitoring of trial safety data to detect risks and report findings to regulators 
• Signal detection methods: Techniques to identify safety signals 
• Signal Evaluation and assessment: Techniques to evaluate and assess safety signals

This webinar provides a practical and comprehensive overview of signal management in pharmacovigilance, aligned with current regulatory expectations in post marketing and clinical trial settings. Participants will gain insight into key principles, processes, and tools used to identify, evaluate, and communicate safety signals across the product lifecycle.

The session will cover the end-to-end signal management process, including detection, validation, prioritisation, evaluation and assessment, escalation, and governance.

Participants will review key signal detection methods, including qualitative approaches and quantitative techniques, supported by commonly used metrics, tools, and criteria.

Finally, the session will highlight how signal information is reflected in PBRERs and RMPs, key regulatory notification requirements across FDA, EMA /MHRA and Swissmedic, and the role of signal tracking systems in ensuring transparency and traceability.