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:
- Global safety database listings and tabulations
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
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.”
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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