Signal Management
in Pharmacovigilance

Identification and evaluation of drugs safety signals 

What is Signal Management?


Detection and evaluation of safety signals associated with the use of a medicine product is an essential part of ongoing pharmacovigilance monitoring and updating the essential information on the known risk-benefit balance, which helps better inform prescribers and dispensers of medicine and ultimately safeguard patients. Guideline on good pharmacovigilance practices (GVP) Annex I – Definitions defines Signal Management as “A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.”

Signal Detection Procedures

QVigilance procedures on continuous and periodic signal detection & management are written in accordance with GVP: Module IX – Signal management for products both pre- and post-authorisation.

On an agreed and documented frequency, we undertake the systematic cumulative review of data from all relevant sources to identify and evaluate potential new signals.

SAFETY SIGNAL DETECTION SERVICES

Sources of data for the detection and subsequent evaluation of safety signals includes, but may not be limited to, the following:

  • Information from global literature screening (e.g. class effects, potential drug interactions etc.)
  • Emerging pre-clinical findings (e.g. teratogenic analysis, effects on pregnancy)
  • Blinded/open label clinical data (e.g. Data and Safety Monitoring Board (DSMB) summaries, clinical study reports, etc.)
  • Regulatory agency information [e.g.
    Pharmacovigilance Risk Assessment Committee
    (PRAC) findings, FDA notices]
  • Information from partners
  • EudraVigilance Data Analysis System (EVDAS) and
    information available from other regulatory databases
  • Competitor product labeling information
Signal-detection-in-pharmacovigilance

Signal Detection Report


Qvigilance offers the creation of Signal detection Reports. Signal detection and evaluation of any new or on-going signals is documented in a report which is medically reviewed and findings assessed for impact on the benefit-risk profile. Additionally, the report may detail recommendations for confirmed signals or this can be discussed and documented via a safety review committee who are responsible for ratification of the findings of the signal detection and evaluation report.

Risk Management System & Safety Signals

 

Our signal management procedures ensure appropriate action can be taken in response to new evidence that may have an impact on the known risk-benefit balance and thus maintains a comprehensive and robust risk management system throughout the life cycle of the product.

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