clinical trilas services

PHARMACOVIGILANCE

What is Pharmacovigilance and how to choose the service provider?

Pharmacovigilance plays a key role in ensuring the quality and safety of pharmacological treatments, involving a complex set of activities aimed at identifying, evaluating, monitoring, and preventing adverse reactions to drugs. Its main objective is to enhance the understanding of the risk-benefit profile of a drug, thereby contributing to the protection of patients’ health.

Carefully choosing a Pharmacovigilance service provider is essential, and therefore, it is crucial to opt for a professional and reliable partner with extensive experience in the field, supported by a team of highly qualified experts. The decision to collaborate with a provider possessing solid multi-year experience ensures accurate and regulatory-compliant management of related activities. Since 2008, VI.REL has positioned itself as a Service Provider capable of meeting the diverse needs of clients, ranging from the complete management of Pharmacovigilance activities to project-based activities.

Choosing our Pharmacovigilance service means relying on a competent and professional team that thoroughly understands the importance of ensuring patient safety and regulatory compliance. Our consolidated experience enables us to offer customized solutions, promoting a comprehensive assessment of the risk-benefit profile of drugs.

OUR SERVICES

Pharmacovigilance in the product life cycle

Qualified Person for Pharmacovigilance (QPPV - EEA/UK) e Deputy QPPV

Our service as a Qualified Person for Pharmacovigilance (QPPV) provides comprehensive support to ensure the effective monitoring of drug safety profiles. Leveraging our extensive experience, we assure meticulous supervision and efficient management of critical documents within the realm of pharmacovigilance. In adherence to GVP guidelines, we pledge 24/7 operational availability, committing to deliver a swift and knowledgeable response at every stage of the pharmacovigilance system. Opting for our QPPV services ensures a complete and dependable management of pharmacovigilance, addressing all regulatory requirements and prioritizing patient safety at the core of our mission.

The Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) assumes a pivotal role in supporting the QPPV in overseeing pharmacovigilance activities, ensuring thorough and competent coverage. Our service encompasses the appointment of a highly qualified Deputy QPPV and the backing of a dedicated team, ensuring the optimal management of pharmacovigilance activities

VI.REL Pharma excels in delivering strong local support for pharmacovigilance in Italy, serving as the primary point of contact for national authorities through the role of the Local Contact Person for Pharmacovigilance (LCP). We engage in vigilant monitoring of Italian legislation and related literature, ensuring meticulous management of reports concerning suspected adverse reactions. VI.REL Pharma is committed to being a dependable partner, providing advanced assistance in establishing and maintaining the pharmacovigilance system for products marketed in Italy

The role of our Pharmacovigilance Physician is dedicated to a thorough understanding and medical evaluation of potential safety issues. They meticulously review and supervise periodic reports, strategically defining literature research. Their expertise plays a crucial role in maintaining a comprehensive and high-quality pharmacovigilance system. Our highly qualified Pharmacovigilance Physician, with substantial experience in the pharmaceutical sector, ensures the effective management of adverse event reports and prompt responses to regulatory inquiries. Choosing our services guarantees professional and competent support, with the ultimate aim of optimizing the safety and efficacy of pharmaceutical products.

VI.REL Pharma delivers a comprehensive service for the management of the Pharmacovigilance System Master File (PSMF). Our range of activities spans the preparation, drafting, and upkeep of the PSMF, all crafted in close collaboration with our clients. Our primary objective is to construct a highly functional document finely tuned to the unique needs of each client, ensuring an advanced and effective pharmacovigilance service while maintaining complete compliance with regulatory requirements.

To ensure a fully tailored and comprehensive pharmacovigilance system, we guarantee the development of Standard Operating Procedures (SOPs) specifically designed for each client. This service encompasses the drafting of various SOPs and related documents, ensuring an integrated and systematic approach to safety management.

The meticulous handling of reports concerning suspected adverse reactions, specifically through Individual Case Safety Reports (ICSRs), stands as a critical aspect within the realm of pharmacovigilance, and VI.REL is dedicated to providing specialized services to ensure a thorough and precise processing of these reports. VI.REL Pharma oversees the entire spectrum of ICSR management, encompassing the collection, analysis, assessment, and submission of reports to regulatory authorities. In our commitment to secure and globally compliant management practices, we employ a validated electronic safety database to uphold the integrity of information within the reports. Our highly specialized team guarantees a prompt response, with a keen focus on the precision and quality of the transmitted data.

To ensure secure and globally compliant management, we extend our services to electronic safety database management, maintaining the information within reports. Our objective is to simplify the process, ensuring the immediate availability of an efficient safety database that aligns with the highest industry standards.

In our pursuit of complete consistency and data integrity within the database, our team maintains constant communication with partners. This bidirectional interaction is strategically designed to ensure a comprehensive understanding of relevant information. Through this collaborative approach, we generate detailed reports, facilitating continuous and accurate monitoring of product safety.

We offer a comprehensive literature monitoring service on a global scale, utilizing functional and tailored search strategies to meet the specific needs of our clients. Leveraging extensive databases through dedicated software, our specialized team excels in designing and implementing effective bibliographic search strategies. We are committed to continuous analysis of literature articles, ensuring a vigilant monitoring of the safety profile and risk-benefit ratio of drugs. Our focus remains sharp on promptly identifying reports related to adverse events or emerging safety issues associated with the use of pharmaceuticals or medical devices of interest.

Our services encompass the activation, monitoring, and upkeep of the Eudravigilance profile for our clients. Our team of experts efficiently manages the input and updates of data in the XEVMPD database (Article 57), aligning with European regulations. This activity facilitates the communication of information related to medicinal products, both pre- and post-authorization, to the European Medicines Agency (EMA), ensuring swift and secure interactions with Marketing Authorization Holders (MAH). Beyond this, our dedication extends to the ongoing monitoring of Individual Case Safety Reports (ICSRs) on the European agency’s platform, guaranteeing the promptness and accuracy of information at all times.

We offer comprehensive services for the detection and management of safety signals, providing innovative and tailored solutions to meet the specific needs of the client. Our highly qualified team is dedicated to the accurate analysis of safety information, aiming to present detailed reports through the preparation of Signal Detection Reports. These documents are crucial for providing our clients with in-depth analysis to guide informed decisions in the context of safety and risk management.

In our commitment to ensuring the safe utilization of medicinal products, we diligently identify and address any potential significant risks associated with these products. We actively contribute to the formulation, drafting, and regular updating of the Risk Management Plan (RMP). This comprehensive document serves to prevent or minimize risks to patients, while also evaluating the effectiveness of risk prevention measures.

We assist our clients in meticulously organizing report submission schedules, orchestrating the gathering of essential information for crafting the Periodic Safety Update Report (PSUR). Throughout this process, we provide a thorough and nuanced analysis of the collected safety information, with the objective of evaluating the risk-benefit equilibrium of a medicinal product. The preparation of these reports adheres rigorously to current regulatory requirements, encompassing the latest PBRER templates in the European Union.

We provide our clients with a comprehensive and in-depth pharmacovigilance training program, enriched with a dedicated educational system and online learning verification. These courses are meticulously crafted following a training plan developed by the Qualified Person for Pharmacovigilance (QPPV), ensuring not only full compliance with regulations but also the maintenance of high safety standards. Our overarching objective is to furnish our clients with robust and up-to-date skills, fostering a culture of responsible pharmaceutical vigilance across all facets involved.

We are committed to ensuring compliance with current regulations through comprehensive audits of pharmacovigilance systems and meticulous data Due Diligence. We verify that all documents align accurately with regulatory provisions. Through a rigorous analysis, we closely examine the capabilities of our clients’ partners, ensuring they can proficiently deliver the stated services. This steadfast commitment is geared towards upholding the highest standards in the pharmaceutical industry.

We provide comprehensive Mock-up inspection services and offer assistance during inspections conducted by competent authorities in the field of Pharmacovigilance. Leveraging our extensive experience in this domain, we guide our clients in identifying and addressing potential critical issues, ensuring thorough preparedness, and delivering an effective response during regulatory inspections. Our support throughout official inspections ensures seamless management and a timely response to the queries of regulatory authorities.

We place special emphasis on nurturing relationships with our clients’ partners and suppliers through the meticulous implementation and management of Safety Data Exchange Agreements (SDEA). By tailoring agreements to the unique needs of our clients, we commit to ensuring that all pharmacovigilance activities align seamlessly with these agreements and adhere to current regulations.

We have established an internal Quality System with well-defined procedures to streamline the efficient exchange of information within our Pharmacovigilance system. Our dedication to quality is exemplified by the clarity and comprehensiveness of the dedicated quality manual, ensuring the precise and timely handling of safety information. Our quality system plays a pivotal role in ensuring that pharmacovigilance activities adhere to the highest standards, ensuring readiness for audits and contributing to the overall compliance of pharmacovigilance systems.