DUBLIN--(BUSINESS WIRE)--The "Signal Detection and Regulatory Expectations Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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.
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.
Key Topics Covered:
The Signal Detection and Regulatory Expectations course will cover:
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 EVDA Ssystem
- Signals arising from EVDAS
Risk-benefit analysis
- Calculating the extent of benefit by indication
- Identifying significant product risks
- Benefit-risk assessments
- Benefit-risk outcomes
Speakers:
Graeme Ladds
Director
PharSafer Associates Ltd.
Graeme Ladds, Director of PharSafer, has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.
For more information about this conference visit https://www.researchandmarkets.com/r/900tt2
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