Signal management in pharmacovigilance is a key process that facilitates safety of the patient by detecting, assessing, and controlling possible safety concerns of medicinal products. Signals are have information implying a new or modified bad event that potentially must be studied or regulated.
Masuu Global is committed to helping pharmaceutical companies fulfill global signal management services to achieve regulatory compliance throughout the world and improve patient safety.
What is Signal Management?
Signal management refers to the process of identifying, validating, evaluating and prioritizing safety signals using several data sources. Such signals can be of unknown risks or shift in number or severity of known unfavorable reactions.
Data and information sources:- Data sources transmitting signals can be very diverse. This may include all the scientific data about the use of the medicinal product, including the result of the use, i.e. quality, non-clinical and clinical, data (including pharmacovigilance and pharmacoepidemiological data)
- Some of the common sources of signals are spontaneous reporting systems, active surveillance systems, studies and scientific literature reporting.
- Signal detection is usually carried out by regular surveillance of suspected adverse reaction databases, which may be of different scope or size, e.g. marketing authorization holder databases, national databases, EudraVigilance, the database of WHO Programme for International Drug Monitoring (VigiBase).
- Signal detection: Applying data mining, statistical methods and subject team reviews to find unusual patterns/trends in safety data using information sources like spontaneous reports, clinical studies, scientific literature and databases.
- Signal validation: Checking whether the signal identified is established on reliable and adequate evidence, such that it makes a distinction between real signals and noise.
- Signal Analysis and Prioritization: Considering the clinical importance, the possible consequences affecting the population health, and the necessity of any additional measures.
- Signal Evaluation: An extensive evaluation that includes clinical, epidemiological and statistical analysis to establish the character of the signal and its cause.
- Risk Communication and Action: Notify regulatory agencies, healthcare professionals and patients, and put risk-minimizing methods into practice where necessary.
The significance of Signal Management.
Managing signals is the critical factor towards:- Early identification of new adverse drug reactions or safety profile transformation of old ones
- Withholding of timely regulatory reporting and compliance
- Allowing proactive risk mitigation to avoid harm caused to patients
- Facilitating evidence-based decisions that healthcare providers and regulators make
Regulatory Requirements
Signal management is a high priority pharmacovigilance exercise of regulators worldwide such as the EMA, FDA, and WHO. ICH E2E guideline and EMA GVP Module 9 offer signal expectations and management structures.
Pharmaceutical companies must develop sound procedures to systematically track safety data, identify signals and respond to them in an adequate way so as to ensure safeguarding of citizens’ health.
Challenges
Processing large amounts of safety data of different origins- Separation of important signals and unimportant background noise or chance occurrences
- Co-ordination of proper assessments
- Organizing multi-disciplinary teams to carry out comprehensive assessment
- Regulatory inspection audit trails and documents Despite the importance of audit documents, few companies perform auditing every day.
How Masuu Global Supports Signal Management
Masuu Global offers expert signal management services, including:- Design and implementation of customized signal detection algorithms
- Continuous monitoring of safety databases and literature
- Medical and statistical review of potential signals
- Prioritization and risk assessment in line with regulatory guidelines
- Preparation of signal management reports and regulatory submissions
- Training and process optimization for internal pharmacovigilance teams
Our tailored solutions help companies detect and respond to safety signals effectively, minimizing risks and ensuring compliance.
Signal management is an essential pharmacovigilance function that protects patients and supports regulatory compliance. By partnering with Masuu Global, you gain access to expert-driven, technology-enabled signal detection and evaluation services designed to keep your products safe in today’s complex regulatory landscape.
Contact us today to learn how we can strengthen your signal management processes and enhance patient safety.