Featuring signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitative assessments.
This course will provide a detailed overview of all aspects of safety reviews and signal detection within a company and will cover signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitative assessments.
Increasingly the most common critical findings in Regulatory Inspections are being given for signal detection and management - so the need to identify potential signals and risks in patients has never been greater. The protection of patients through robust and clear methodologies for signal detection amidst the ever increasing regulations requires that Companies need to have trained and competent staff to perform such activities.
- Clarify the EU regulatory requirements for signal detection
- Understanding the new frequency requirements for safety review
- How to use the Eudravigilance quantitative signal tool
- Understand the safety review cycle and the safety review meeting and process
- Discuss safety communication - the CCSI/SCSI and labelling
- Gain a better understanding of risk benefit analysis - benefit-risk assessments and benefit-risk outcomes
- An introduction to safety signals
- The regulatory requirements for signal detection - Module IX
- The signal review cycle
- Causality and signal detection
- The safety review meeting and process
- Quantitative signal analysis
- Quantitative and qualitative signal detection
- Signals and their discussion
- Risk benefit analysis
- Safety assessments life cycle
For more information about this conference visit https://www.researchandmarkets.com/research/5pqkhh/2_day_course?w=4