Signal Detection and Management.
What is a Safety Signal in pharmacovigilance?
The CIOMS Working Group 8 definition is:
“…information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action”.
https://cioms.ch/wp-content/uploads/2018/03/WG8-Signal-Detection.pdf
The EMA’s definition of a safety signal is:
“A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.”.
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management
A safety signal is therefore new or additional information which warrants further analysis and verification to establish a connection between an adverse or beneficial effect and a product.
How do you perform Signal Detection and management?
The detection of safety signals for further evaluation comes from the deeper analysis of data from a range of sources including:
- Spontaneous adverse effect reports.
- PSUR and PBRER aggregate reports.
- Active monitoring systems.
- Clinical trials.
- Pharmacoepidemiology studies.
- Literature reviews.
- Meta-analysis of clinical trial data.
- The EMA’s Eudravigilance and FDA’s FAERS databases.
- Other relevant sources of information.
The management of safety signals must follow a systematic order:
- Signal detection.
- Validation and Confirmation.
- Analysis.
- Prioritization.
- Assessment.
- Recommendation of action.
The aim of this process is to establish whether or not there is a credible causal relationship between reported adverse events and specific medicinal products/conditions, and to indicate any required action to reduce that risk.
Why use Arriello’s Signal Detection and Management service?
There is no one-size-fits all solution to signal detection and management and our approach is tailored to your product and safety organization.
Our experienced pharmacovigilance team has the expertise to manage the efficient and effective detection and management of Signals for all your investigational and authorized medicinal products, optimizing your patients’ safety, and assuring the compliance of your PV system.
All signals undergo Validation, Prioritization, and Assessment in a manner that ensures continued patient safety. Working as part of your safety team, and alongside relevant stakeholders, we’ll request, collate and assess the sources of safety information ahead of presenting findings using our proven signal trackers and agreed data outputs/visualizations to your Safety Management Team.
Our signal detection and management approach is further aligned to the management of your product’s benefit-risk.
What is Safety communication?
Safety communication is a broad term covering different types of information on medicinal products to healthcare professionals, patients, and other stakeholders.
It is directly connected to Signal Management because it is so frequently the action recommended at the end of the systematic signal assessment process.
Our safety experts can support you to effectively propose, develop and distribute your safety communications, including routine communications such as a Summary of Product Characteristics (SmPC) or Package Information Leaflet (PIL), plus additional routes of communication to communicate newly identified important safety concerns that can have an impact on a medicine’s benefit-risk balance and its condition of use.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.