Signal Management In Pharmacovigilance

https://fleming.events/signal-management-in-pharmacovigilance/

This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication. The series of talks, discussions & exercises will bring clarifications about the regulation & methodologies for signal detection, what to consider in signal validation and prioritisation, how to notify regulatory agencies and avoid inspection findings related to signal management.

Topics

• Signal detection
• Signal validation & assessment
• Signal communication

Benefits of attending

• Understand the regulations & guidance on signal management.
• Get an overview of qualitative and quantitative methodologies for signal detection.
• Explore the role of social media in signal detection.
• Learn about signals of disproportionate reporting.
• Reveal what to consider in signal validation and prioritization.
• Be introduced to EVDAS and expectations on its use
• Consolidate your learnings with interactive scenario-based discussions
• Learn how signal management links with PSUR & Risk Management Plans
• Get expert insights on signal communication.
• Understand implementation, oversight and governance of the signal management process in the company.
• Reveal potential inspection findings related to signal management and learn how to avoid them.