Two Day Signal Detection and Regulatory Expectations Training Course (November 29-30, 2022)
Dublin, Aug. 16, 2022 (GLOBE NEWSWIRE) -- The "Signal Detection and Regulatory Expectations Training Course" conference has been added to ResearchAndMarkets.com's offering.
Including the updated Signal Module IX and EudraVigilance quantitative signal requirement
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.
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.
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
Key Topics Covered:
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
For more information about this conference visit https://www.researchandmarkets.com/r/y05a9o
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900