Pharmacovigilance is a critical component of the medicinal product lifecycle, focusing on ensuring the safety and efficacy of medicinal products from pre-clinical development through post-marketing surveillance. The primary goals of pharmacovigilance are to enhance patient safety, manage risks, and strengthen public health and trust in therapeutic products.
Regulatory bodies mandate rigorous vigilance to detect and monitor known and potential adverse drug reactions (ADRs) across diverse patient populations. These efforts include monitoring factors such as dose-related reactions, patient-specific variables, and product formulation quality, both before and after a product enters the market.
Qinecsa is a trusted leader in pharmacovigilance, offering comprehensive solutions at every stage of the product life cycle. As an industry leader in end-to-end clinical and post-marketing pharmacovigilance (PV), Qinecsa provides services including case management, aggregate reporting, signal and risk management, literature management, Qualified Persons for Pharmacovigilance (QPPV) services, auditing, and advanced safety database and PV technology solutions.
The Role of Pharmacovigilance in Healthcare
Dedicated to the secure use of medications. This discipline involves detecting, assessing, understanding, and preventing adverse drug effects and medication-related problems.
Pharmacovigilance plays a pivotal role in global healthcare by ensuring the safety and efficacy of medicinal products across diverse populations. As the use of pharmaceuticals continues to grow worldwide, so does the need for rigorous monitoring of ADRs and medication-related problems. According to the World Health Organization (WHO), ADRs are responsible for nearly 10% of hospital admissions in some countries, underscoring the importance of effective pharmacovigilance systems in minimising harm and optimise therapeutic outcomes. In 2022, over 1.25 million serious adverse events (AEs) were reported globally, highlighting the ongoing challenges in drug safety that necessitate robust pharmacovigilance practices.
From a global perspective, pharmacovigilance also contributes significantly to public health by enabling the early detection of safety issues that may not have been evident during clinical trials. This is particularly crucial in low- and middle-income countries, where healthcare systems may be less equipped to handle the consequences of widespread adverse drug reactions. The establishment of international pharmacovigilance networks, such as the WHO Programme for International Drug Monitoring, has facilitated the sharing of safety data across borders, promoting a collaborative approach to drug safety. This global effort has proven essential in preventing large-scale health crises and ensuring that the benefits of medications outweigh their risks on a population level.
Qinecsa services and technology were developed from understanding the crucial importance of an efficient and compliant pharmacovigilance system. As a trusted global partner, Qinecsa offers extensive scientific, medical, and regulatory expertise across the entire lifecycle of medicinal products, covering a broad geographical reach. With best-in-class technological capabilities, robust PV and quality assurance processes, and teams of formidable PV experts, the company offers comprehensive support to life sciences companies, regulators, and public health organisations, all while maintaining a cost-effective outlook.
Regulatory and Procedural Guidance on Pharmacovigilance
To reduce the incidence of adverse drug interactions, the pharmacovigilance framework has evolved into a tightly regulated system that harmonises safety practices across regions. International and national regulatory agencies, including the WHO’s International Drug Monitoring program, the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), have pioneered the development of this global framework.
These regulations provide essential structure to the pharmacovigilance process, but the complexity of medication safety protocols, coupled with the need to consolidate and analyse extensive data sources, often complicates drug development phases.
For nearly two decades, Qinecsa has successfully delivered safety services to over 75 pharmaceutical and biotechnology clients across Europe, the US, Australia, the Middle East, and Asia. The global team of scientific and medical experts supports clinical and post-marketing pharmacovigilance services for approximately 5,000 medicinal products in over 100 countries, developed by life sciences clients of all sizes. Qinecsa services span diverse therapeutic areas such as oncology, nephrology, respiratory, neurology, and rare diseases, all while meeting global and local PV and regulatory guidelines.
What Are the Objectives of Pharmacovigilance?
Pharmacovigilance plays a crucial role in ensuring that medicinal products are used safely and effectively. At its core, pharmacovigilance aims to protect public health by preventing harm from known and potential adverse reactions that may arise during the authorised use of medications. The objectives of pharmacovigilance can be categorised into several key areas, each focused on maintaining and enhancing patient safety.
1. Ensuring Continuous Monitoring and Vigilance
A fundamental objective of pharmacovigilance is to establish and maintain an effective system for monitoring medicinal product safety issues. This involves creating a robust, compliant, and efficient pharmacovigilance infrastructure that serves as a single source of truth for patient interactions with medicinal products. By staying ahead of potential risks, regulatory authorities, healthcare professionals, and pharmaceutical companies are empowered to prevent or minimise adverse reactions and other safety concerns associated with medicinal product use.
2. Enhancing Patient Care and Safety
Pharmacovigilance is inherently patient-centric, dedicated to safeguarding patient well-being throughout the lifecycle of a medicinal product. Continuous assessment of emerging safety issues and the evolving risk profile of known concerns enables proactive management of product-related risks. This proactive approach ensures that any new or changing safety concerns are swiftly identified and addressed, promoting informed and safe medication use. Additionally, pharmacovigilance systems facilitate timely updates to product labels and safety warnings, ensuring that healthcare providers and patients have access to the most current safety information.
3. Implementing Appropriate Risk Management Strategies
In the event of a safety concern, an effective pharmacovigilance system adopts a systematic approach to risk management. By thoroughly assessing ADR reports, electronic health records (EHRs), prescription data, and other relevant sources, the system can identify and evaluate potential risks or the changing character of the identified risks. Based on these assessments, appropriate actions are recommended, such as updating product labels, issuing safety warnings, or in severe cases, withdrawing the product from the market. These strategies are crucial for mitigating risks and maintaining the trust of patients and healthcare professionals.
4. Ensuring Compliance with Regulatory Requirements
Another key objective of pharmacovigilance is to ensure that all activities align with international and local regulatory requirements. Compliance is essential for the timely and accurate reporting of safety data to regulatory authorities, which in turn, upholds public health standards. By maintaining adherence to these regulations, pharmacovigilance systems contribute to the broader goal of drug safety and efficacy on a global scale.
5. Leveraging Technology for Enhanced Safety Monitoring
With the advancements in pharmacovigilance technology, tools such as safety databases, artificial intelligence, and data analytics have become integral to achieving these objectives. By utilising platforms like Qinecsa’s HALOPV, Reportum, and Commonwealth Vigilance Workbench (CVW), pharmacovigilance activities are streamlined, enabling more efficient signal detection, case management, and reporting processes. These technological capabilities not only enhance the accuracy and efficiency of pharmacovigilance operations but also ensure that safety concerns are identified and addressed with unprecedented speed and precision.
Pharmacovigilance is essential to the safe and effective use of medicinal products, serving as a vital safeguard for public health. Through continuous monitoring, patient-centric care, rigorous risk management, regulatory compliance, and the use of advanced technology, pharmacovigilance systems ensure that potential safety issues are swiftly identified and managed. As a leader in this field, Qinecsa is committed to delivering comprehensive pharmacovigilance services that meet the highest standards of safety and regulatory compliance, ultimately contributing to improved patient outcomes and the overall quality of healthcare.
Key Phases of Pharmacovigilance
Pharmacovigilance is an established discipline in pharmaceutical development, grounded in sound science and focused on ensuring medicinal product safety throughout the lifecycle of a product. The key areas of pharmacovigilance cover research, detection, assessment, understanding, and prevention of adverse drug reactions.
Clinical Trials
Pharmacovigilance procedures and safety reporting obligations are essential for managing clinical trials. These protocols play a key role in identifying emerging safety signals and evaluating the efficacy of a drug product before it receives marketing approval.
Regulatory authorities require continuous information throughout the trial process to evaluate the benefit-to-risk ratio of medications under review. For instance, all Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported to regulators within seven days if classified as fatal or life-threatening, and within 15 days for other SUSARs.
These stringent safety monitoring operations continue throughout clinical trials, from patient recruitment to closeout. Standard Operating Procedures (SOPs) are maintained to ensure compliance with regulatory guidelines, anticipating associated hazards by outlining and updating Developmental Risk Management Plans (dRMPs) to maximise safety during the trial.
Trial protocols also include continuous literature review to stay ahead of safety developments in similar research fields. During the trial phase, observed safety signals and adverse reports are carefully documented, with procedures in place to integrate these findings into broader pharmacovigilance operations.
Staying ahead of these regulatory requirements and requisite literature surveillance can be challenging, with costly penalties and delays in time-to-market resulting from any shortcomings.
Qinecsa works in continuous partnership to ensure clinical trial safety reporting compliance. The company processes over 200,000 Serious Adverse Events (SAEs) annually and supports more than 100 clinical studies across our global client portfolio. Qinecsa experts excel in accurately categorising and assessing trial adverse events, from non-serious adverse events and adverse reactions to SUSARs. A key component of the service also includes the skilled handling of the complexities of various trial formats, such as unblinding the trial medicinal product to make expedited SUSAR reports.
Market Authorisation
Continuous monitoring is required beyond the clinical trial phase and extends throughout the lifecycle of the medicinal product after it has been approved. During the market authorisation process, robust pharmacovigilance systems are critical for identifying potential risks that may not have been identified during clinical trials.
Global regulations, including those across the European Economic Area (EEA) and other jurisdictions, require the Marketing Authorisation Holder (MAH) to establish comprehensive systems and processes for continuous monitoring of pharmacovigilance data. These systems must be optimised for risk management and ready to implement appropriate measures in response to adverse events associated with medicinal products.
As the regulatory liaison, the MAH is responsible for evaluating and communicating all risk-related information concerning medicinal products that could affect patient safety or public health. This information must be accurate, verifiable, and promptly reported to competent authorities within the legally mandated timeframes.
Authorities such as the EMA, FDA, and PMDA establish and uphold effective systems and procedures to ensure that the structure, quality, and comprehensiveness of pharmacovigilance are thoroughly evaluated. Clear and consistent communication between the MAH and these authorities is crucial to ensuring the safety of pharmaceutical products both upon entering the market and during the renewal of market authorization. This process relies heavily on the safety data often gathered from Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs) or PADERs (Periodic Adverse Drug Experience Reports).
Post-Marketing Surveillance
Post-marketing surveillance is critical as the drug is introduced to a broader and more diverse patient population that may not have been represented during clinical trials. This stage of pharmacovigilance ensures that any adverse effects, interactions, or long-term risks that emerge after a drug’s release are carefully monitored and managed.
Qinecsa’s post-marketing surveillance services include rigorous and proactive signal detection and management, with expertise in managing both active and passive surveillance systems. The company excels in analysing large volumes of safety data to identify emerging risks and trends that could impact patient safety. Employing advanced data analytics and artificial intelligence ensures that potential safety signals are detected early, allowing for timely interventions and risk mitigation strategies.
Key Phases of Pharmacovigilance
Individual Case Safety Reports (ICSR) Management
Pharmacovigilance processes during post-marketing can be conducted through two primary methods: active and passive surveillance systems.
- Active Surveillance: Active surveillance involves a proactive approach to gathering post-marketing safety data. Pharmaceutical companies and regulatory bodies systematically collect comprehensive information to determine the benefit-risk profile of a drug after it has been released to the market. This includes sourcing data on adverse reactions with other medications, delayed or long-term effects, and negative reactions in specific populations. Data sources for active surveillance may include healthcare databases, such as claims data, prescription event monitoring systems, and electronic health records (EHRs).
- Passive Surveillance: Passive surveillance relies on spontaneous reporting systems, where reports of suspected ADRs are submitted by healthcare professionals, consumers, and pharmaceutical companies to regulatory authorities. Notable programs, such as the “Yellow Card Scheme” in the United Kingdom and the “MedWatch” program in the United States, are key sources of data collection for drug reactions. These systems play a critical role in monitoring the safety of medicinal products and identifying potential risks post-marketing.
Qinecsa’s Qualified Persons for Pharmacovigilance (QPPVs) are available 24 hours a day to provide safety information to regulatory authorities about products in development or on the market. They are experts in medicine, pharmaceutical sciences, and related areas, with extensive theoretical and practical pharmacovigilance knowledge. These professionals ensure regulatory compliance and uphold pharmacovigilance best practices.
Qinecsa’s safety team processes over 1.5 million ICSRs annually and performs over 60,000 submissions each year. Their scientists and physicians are extensively trained in Qinecsa’s own HALOPV, Argus and ArisG in addition to other commercially available safety databases and MAH’s home-grown systems, , to expertly process ICSRs and manage drug safety information. Qinecsa submissions staff are highly skilled in facilitating electronic reporting, while project managers ensure efficient case tracking, monitor turnaround times (TAT), and uphold quality compliance using validated in-house tracking platforms.
Literature Surveillance
Literature surveillance refers to the ongoing review and monitoring of scientific and medical literature to identify information related to the safety of medicinal products. This includes the identification of ADRs, new safety signals, and other relevant safety data that may impact the benefit-risk profile of a medicinal product.
The primary goal of literature surveillance is to capture any new or previously unreported safety information that might emerge from published studies, case reports, reviews, and other scholarly articles. It ensures that safety data are continuously updated and integrated into the pharmacovigilance system.
- Systematic Review: Regular scanning of scientific journals, databases, and publications for relevant information.
- Data Extraction: Identifying and extracting information on ADRs, new risks, and safety concerns.
- Integration into PV System: Incorporating findings into safety databases, reporting to regulatory authorities, and updating risk management plans (RMPs).
Literature surveillance is a continuous process that begins before clinical trials and extends through market authorization and beyond. In the preclinical and clinical phases, it informs the development process by ensuring that existing knowledge is integrated into the research and safety assessments.
As the drug moves toward market authorisation, literature surveillance ensures that the most up-to-date information is considered in regulatory submissions. In the post-marketing phase, it remains a key component of ongoing pharmacovigilance, helping to monitor the drug’s safety in real-world use.
Signal Management and Risk Minimisation
Effective signal management is essential for identifying new safety information that may impact the benefit-risk profile of a medicinal product. The process involves detecting, validating, prioritising, and assessing signals, followed by recommending regulatory actions if necessary.
Qinecsa employs a robust signal management process that integrates data from various sources, including spontaneous reporting systems, literature, clinical trials, and observational studies. By leveraging advanced pharmacovigilance databases and tools, Qinecsa’s experts can efficiently identify and evaluate safety signals, ensuring that they are properly documented and communicated to regulatory authorities.
Risk minimisation strategies are implemented to mitigate the risks identified during signal detection or any other PV process. These strategies may include updating product labelling, restricting product use, implementing risk communication plans, or even withdrawing the product from the market if necessary. Qinecsa’s team works closely with clients to develop and execute tailored risk minimisation strategies that comply with regulatory requirements while ensuring patient safety.
Aggregate Reporting
Aggregate reporting is a critical component of pharmacovigilance, providing a comprehensive assessment of a medicinal product’s safety profile over time. This includes the preparation of PSURs, PBRERs, PADERs and other regulatory submissions that summarise safety data and periodically assess the benefit-risk balance of the product.
Qinecsa’s pharmacovigilance experts are proficient in preparing high-quality aggregate reports that meet global regulatory standards and prepare over 900 such reports annually across myriad of therapeutic areas and products. These reports are essential for ongoing regulatory compliance and for making informed decisions about the continued use of a medicinal product in the market. Qinecsa’s team ensures that all relevant safety data are included in these reports, providing a clear and accurate picture of the product’s safety profile.
Technology and Data Management
In the fast-evolving field of PV, technology and data management play a crucial role in ensuring the safe and effective use of medicinal products. As the volume of data generated in clinical trials and post-marketing surveillance grows exponentially, advanced technological solutions are necessary to efficiently collect, analyse, and report safety information. Industry standards demand a high level of accuracy, compliance, and speed in managing this data, making robust pharmacovigilance platforms indispensable for pharmaceutical companies.
The pharmacovigilance industry is governed by stringent regulatory standards such as the Good Pharmacovigilance Practices (GVP) guidelines from the EMA, the U.S. FDA regulations, and the ICH guidelines. These regulations require pharmaceutical companies to implement comprehensive PV systems capable of detecting, assessing, and reporting ADRs in a timely and accurate manner.
To meet these standards, pharmacovigilance systems must offer advanced data management capabilities, including automated signal detection, real-time data integration, and robust reporting tools. Moreover, these systems need to be flexible enough to adapt to the evolving regulatory landscape and scalable to manage the increasing data demands of global pharmacovigilance operations.
Qinecsa, a leader in the pharmacovigilance industry, offers three cutting-edge platforms that exemplify the integration of technology and data management in PV: Reportum, HALOPV suite for end to end PV, and the CVW Platform. These platforms are designed to meet and exceed industry standards, providing pharmaceutical companies with the tools needed to ensure compliance, enhance safety monitoring, and improve overall data management.
Reportum Platform
The Reportum Platform is a state-of-the-art data capture tool specifically designed for collecting, managing, and analysing AE data. It facilitates the efficient intake of high-quality data from multiple sources, including healthcare professionals, patients, and clinical trial participants. With its intuitive user interface and customizable workflows, Reportum streamlines the process of adverse event intake , ensuring that data is accurate, complete, and compliant with regulatory requirements. The platform’s robust analytics capabilities enable users to identify trends in the data, supporting proactive risk management and decision-making.
HALOPV
HALOPV is Qinecsa’s comprehensive pharmacovigilance technology solution, offering end-to-end case management, literature surveillance, aggregate reporting, signal management, Safety Data Exchange Agreements (SDEAs) management, Quality and Compliance, and safety reporting functionalities. Designed to handle large volumes of safety data, HALOPV platform is fully compliant with global regulatory standards, including E2B (R3) data exchange formats, and offers advanced features such as automated case triage, signal detection, and global regulatory submissions. HALOPV’s integration capabilities allow seamless data exchange with other PV systems and EHRs, ensuring that all relevant safety information is captured and analysed in real-time.
CVW Platform
The CVW Platform is Qinecsa’s innovative tool for managing clinical and post-marketing signal surveillance activities. CVW provides a centralised workspace for managing signal pertinent PV workflows, including literature surveillance, signal management, and risk assessment. The platform’s modular design allows users to tailor the system to the MAH’s specific needs, whether they are focused on clinical trial safety or post-marketing surveillance. CVW’s advanced data visualisation tools and dashboards enable users to monitor key safety metrics and track the progress of signal activities in real-time, facilitating more informed decision-making and ensuring compliance with regulatory obligations.
Qinecsa’s Reportum, HALOPV, and CVW platforms represent the forefront of pharmacovigilance technology, offering comprehensive solutions for data management and regulatory compliance. By integrating these platforms into their PV operations, pharmaceutical companies can enhance their ability to monitor drug safety, reduce the risk of adverse events, and ultimately improve patient outcomes. As the pharmacovigilance landscape continues to evolve, the role of technology and data management will only become more critical, making these platforms essential tools for the future of drug safety.
The Future of Pharmacovigilance
With the global nature of the pharmaceutical industry, ensuring compliance with diverse regulatory requirements across different regions is a significant challenge. The value of offering a global pharmacovigilance solution that ensures compliance with international and local regulations, regardless of the geographic location of the product, cannot be understated.
Pharmacovigilance is a critical aspect of the drug development and post-marketing process, ensuring that medicinal products are safe and effective for patients. Comprehensive pharmacovigilance services cover the entire lifecycle of a product, from clinical trials to post-marketing surveillance, signal management, risk minimization, aggregate reporting, and global compliance.
By partnering with a company like Qinecsa, pharmaceutical companies can ensure that their pharmacovigilance systems are robust, compliant, and effective in safeguarding patient safety. Expertise, advanced technologies, and global reach validate the choice of a single trusted partner for all pharmacovigilance needs, helping clients navigate the complex regulatory landscape and maintain the highest standards of product safety.
