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.
- 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.