Signal Detection and Regulatory Expectations Programme Course Including the Updated Signal Module IX and EudraVigilance Quantitative Signal Requirement (London, United Kingdom - November 25-26, 2019)
DUBLIN, July 29, 2019 /PRNewswire/ -- The "Signal Detection and Regulatory Expectations" conference has been added to ResearchAndMarkets.com's offering.
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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
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 newly revised 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
A certificate of attendance for professional development will be available to each participant who completes the course
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.
Agenda:
Programme - Day One
09.00 Registration and refreshments
09.30 An introduction to safety signals
- History of safety signals
- The nature of safety signals
- The definition of safety signals
- Safety sources for signal detection
10.15 Causality and signal detection
- Causality assessments for signal review
- Data quality in safety assessments
- Causality versus incidence (DMEs and IMEs)
- Generic and innovator products
11.15 Refreshments
11.35 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
12.30 Safety assessments life cycle
- Pre-clinical safety
- Clinical safety
- Class-related safety issues
- Post-marketing safety
- Product suspensions/withdrawals
13.00 Lunch
14.00 Safety assessments life cycle
(continued)
14.30 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
15.30 Refreshments
15.50 The signal review cycle
- Safety profiling
- Signal detection, validation, confirmation
- Analysis and prioritisation,assessment
- Recommendation for action
17.00 Close of day one
Programme - Day Two
09.00 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
10.00 Signals and their discussion
- Signals and DSURs
- Signals and PSURs/PBRERs
- Signals and risk management plans/REMs and minimisation
- Signals and labelling
11.00 Refreshments
11.20 Safety communication
- The CCSI/DCSI and labelling
- Triaging for safety amendments
- Emerging safety issues
- Urgent safety restrictions
- Product suspension and withdrawal
12.30 Lunch
13.30 Quantitative signal analysis
- Signal detection methodologies
- Background - why quantitative signal detection?
- Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
- Regulatory and industry activity (including EudraVigilance)
14.30 EVDAS and the EU
- The PRAC and signals
- The EVDAS system
- Signals arising from EVDAS
15.30 Refreshments
15.50 Risk-benefit analysis
- Calculating the extent of benefit by indication
- Identifying significant product risks
- Benefit-risk assessments
- Benefit-risk outcomes
16.30 Close of course
For more information about this conference visit https://www.researchandmarkets.com/r/aq0y9a
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