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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
Details
Course overview
Including the updated Signal Module IX and EudraVigilance quantitative signal requirement
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 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 signal management and quantitative assessments.
Benefits of attending:
- Clarify the EU regulatory requirements for signal detection
- Learn to use the EudraVigilance quantitative signal tool
- Understand the safety review cycle and the safety review meeting and process
- Understand EVDAS functionalities and outputs
- Discuss safety communication – the CCSI/SCSI and labelling
- Gain a better understanding of risk-benefit analysis – benefit-risk assessments and benefit-risk outcomes
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
Presenter
Graeme Ladds (More...)
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
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1-2 Nov 2021 Live webinar |
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1-2 Nov 2021 Live webinar |
GBP 1,299.00 EUR 1,859.00 USD 2,098.00 + VAT @ 20.00% |
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to attend Live webinar |
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22-23 Feb 2022 Face-to-face, (venue not yet confirmed) |
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22-23 Feb 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 18 Jan 22* |
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to attend Face-to-face (venue not yet confirmed) |
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16-17 May 2022 Live webinar |
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16-17 May 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 11 Apr 22* |
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to attend Live webinar |
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29-30 Nov 2022 Live webinar |
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29-30 Nov 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 25 Oct 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code