Signal Detection and Regulatory Expectations

Increasingly, the most common critical findings in regulatory inspections are being given for signal detection and signal 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 companies to have trained and competent staff to perform such activities.

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 updated Module IX (and addendum) signal management and the links to RMP/REMs; Benefit-Risk determinations and quantitative signal assessments.

Practical examples and exercises are performed throughout the course.

Benefits of attending:

• Clarify the EU/FDA regulatory requirements for signal detection
• Data sources to be used in signal detection
• Learn to understand the EudraVigilance quantitative signal tool utilising the EVDAS functionalities and outputs
• Understand the safety review cycle and the safety review meeting and process
• Discuss safety communication – the CCSI/SCSI and labelling
• Processes for urgent safety restrictions
• Gain a better understanding of risk-benefit analysis – benefit-risk assessments and benefit-risk outcomes
• Understand the influence of signals on RMPs/REMs and PASS
• Practical examples and scenarios for delegates to consider and work on