Two Day Course: Signal Detection and Regulatory Expectations (London, United Kingdom - November 25-26, 2018) - ResearchAndMarkets.com

The "Signal Detection and Regulatory Expectations" conference has been added to ResearchAndMarkets.com's offering.

Featuring signal evaluation for both innovator and generic products under the newly revised 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 that Companies need 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 in attending:

• Clarify the EU regulatory requirements for signal detection
• Understanding the new frequency requirements for safety review
• How to use the Eudravigilance quantitative signal tool
• Understand the safety review cycle and the safety review meeting and process
• 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 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:

Day One

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 a safety review signal trackers
• Information and templates for safety review
• 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 and withdrawals

Safety assessments life cycle continued

The regulatory requirements for signal detection - Module IX

• The frequency of safety reviews (risk assessment)
• The EU and signal detection requirements
• The USA requirements for signal detection
• 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

Day Two

Quantitative and qualitative signal detection

• 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

View source version on businesswire.com: https://www.businesswire.com/news/home/20180918005832/en/