During this presentation participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management session, pragmatic approaches, real life examples, lessons learned, as well as processes for signal management and eRMR assessment will be discussed.
- Routine signal detection methods in EudraVigilance
- Ongoing monitoring activities for signal detection
- Enhanced quantitative signal detection methods (data mining)
- Qualitative vs. quantitative assessment of ICSRs