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.
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
- Clarify the EU/FDA regulatory requirements for signal detection and 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
- Explore processes for urgent safety restrictions
- Gain a better understanding of risk-benefit analysis – benefit-risk assessments and benefit-risk outcomes
- Know the influence of signals on RMPs/REMs and PASS
- Investigate practical examples and scenarios for delegates to consider and work on
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Average rating 4.5
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Overall, the speaker was very competent and added a lot of real-world examples and thus enabled better understanding of the theory/regulatory requirements presented. He is an ex...