Keep ahead of your safety signals with a superior partner

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Safety signals can be detected from various sources, such as spontaneous reports, clinical studies, and scientific literature. The EudraVigilance database (EVDAS) is an important source of information on suspected adverse reactions and signals.

The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. There could be confounding factors, too.

The assessment of safety signals establishes whether or not there is a causal association between the medicine and the reported adverse event.

Evaluating safety signals is part of the routine pharmacovigilance process. It is essential to ensure that regulatory authorities have the most up-to-date information on a medicine’s benefits and risks.

PLG’s Management of safety signals includes the following process:

– Data collection/listing extraction from the safety database

– Literature search (if applicable)

– EVDAS monitoring (if applicable)

– Safety signal report writing

– Quality check/review

– Finalization/approval

– Proposal of actions/measures

We also offer clients an annual signal meeting or drug safety meeting, where we can discuss the safety analysis of their product portfolio. This results in a dynamic plan to address any safety concerns and a strategy for mitigation plans. We have a well-established process in place to report emerging safety issues within stringent regulatory timelines.

Having PLG as a reliable partner to support signal detection and management provides you with multiple advantages

We have a dedicated team of healthcare professionals and physicians who perform complete signal management activities, including signal detection, validation, analysis and prioritization, assessment, and recommendation for action. We offer highly qualified, dynamic, and multilingual technical expertise for global signal management activities. As per EU guidelines, we also have an expert team for signal detection from the EudraVigilance database (EVDAS). Our signal management team ensures that regulatory compliance is met for MAH.

KEY FIGURES:

Some highlights of our signal management expertise are:

500+

APIs under signaling

1500+

drug event pairs evaluated annually

650+

signal detection reports/safety review documents prepared and managed annually

35

global clients, we provide signal management services in various regulatory markets