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Signal Detection and Regulatory Expectations Training Course
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
29-30 Nov 2022
Details
Course overview
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
Who should attend
This course will be of interest to all those working in drug safety/pharmacovigilance as well as regulatory personnel responsible for amending the labelling for products and for the production of the CCSI/DCSI.
Programme
An introduction to safety signals
- History of safety signals
- The nature of safety signals
- The definition of safety signals
- Safety sources for signal detection
Causality and signal detection
- Causality assessments for signal review
- Data quality in safety assessments
- Causality versus incidence (DMEs and IMEs)
- Generic and innovator products
The safety review meeting and process
- Setting up a safety review
- Risk determinations for safety review signal trackers
- Information and templates
- Logistical safety and product safety
- Information from safety reviews
Safety assessments life cycle
- Pre-clinical safety
- Clinical safety
- Class-related safety issues
- Post-marketing safety
- Product suspensions/withdrawals
The regulatory requirements for signal detection – Module IX
- The frequency of safety reviews (risk assessment)
- The EU and US signal detection requirements
- Signal detection and benefit-risk assessments
- The regulators and signals
The signal review cycle
- Safety profiling
- Signal detection, validation, confirmation
- Analysis and prioritisation, assessment
- Recommendation for action
Quantitative and qualitative signal detections
- Standard MedDRA queries (SMQs) and signal detection
- ICSRs and case quality
- Follow-up methodology and regulatory requirements
- Events of special interest
Signals and their discussion
- Signals and DSURs
- Signals and PSURs/PBRERs
- Signals and risk management plans/REMs and minimisation
- Signals and labelling
Safety communication
- The CCSI/DCSI and labelling
- Triaging for safety amendments
- Emerging safety issues
- Urgent safety restrictions
- Product suspension and withdrawal
Quantitative signal analysis
- Signal detection methodologies
- Background – why quantitative signal detection?
- Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
- Regulatory and industry activity (including EudraVigilance)
EVDAS and the EU
- The PRAC and signals
- The EVDAS system
- Signals arising from EVDAS
Risk-benefit analysis
- Calculating the extent of benefit by indication
- Identifying significant product risks
- Benefit-risk assessments
- Benefit-risk outcomes
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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29-30 Nov 2022 Live webinar 09:00-16:30 UK (London) |
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29-30 Nov 2022 Live webinar 09:00-16:30 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 25 Oct* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.