Two Day Signal Detection and Regulatory Expectations Training Course (November 29-30, 2022)

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Dublin, Aug. 16, 2022 (GLOBE NEWSWIRE) -- The "Signal Detection and Regulatory Expectations Training Course" conference has been added to'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

CONTACT: CONTACT: Laura Wood, Senior Press Manager 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