seQure, a business unit of Arithmos, takes a look at the concept of adverse event and possible criteria established by EMA to identify serious adverse events.
In recent years, the European Regulatory Authorities have launched a number of new initiatives to improve the field of Pharmacovigilance, which paved the way for new European legislation adopted in 2012. These efforts have also included the creation of the Pharmacovigilance Risk Assessment Committee (PRAC), known for improving the EudraVigilance database, public pharmacovigilance with the introduction of new training courses and a new medical monitoring services. Other important PRAC objectives include a faster intervention on patients by the regulatory authorities and a greater network that allows various drug users to exchange information.
These improvements can be applied in a wide range of medical events, which can happen for different reasons, mostly categorized as “serious”; causing the EMA to make a list of criteria to help pharmaceutical companies identify the right level of severity of them.
An adverse event can be defined as an “any unfavorable episode of a medical nature that happens to a patient or a subject participating in a clinical trial in which a pharmaceutical product is administered and does not necessarily have a causal relationship with this treatment “.
Therefore, the EMA decided to list them all, along with the working group of experts EudraVigilance. These were as follows:
- Death
- Deadly disease
- Request hospitalization or prolongation of hospitalization
- Results in persistent or significant disability / invalidity
- Congenital anomaly / birth defect
seQure, a business unit of Arithmos, recommends use of expert support for all Pharmacovigilance operations, in order to obtain the best results in terms of Quality & Compliance. seQure, a business unit of Arithmos, provides consulting services for drug safety and risk management for the collection, monitoring, evaluation and analysis of information on drug safety and the detection of new adverse events. Our team is composed of personnel with 30 years of experience in the area of pharmacovigilance and headed by a Director who is a qualified EU QPPV.
About Arithmos
We are Business and Technology experts in the Life Science industry.
We help companies to gain the best business value through technology-enabled solutions. With our business units seQure and The CQA Company, we provide Quality Compliance and Consulting services.
We deliver solutions and services for:
- Pharmacovigilance and Safety
- Regulatory Document Management
- Reporting & Analytics
- eClinical
- Cloud Services
- IT Services
- Quality Management
- Computer System Validation
- Regulatory Affairs
Our industry-leading experts combine the knowledge of processes and technologies to implement your digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.
We support your:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management
