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Navigating the Pharmacovigilance Software Maze: Overcoming Implementation Challenges

May 29, 2024 | Pharmacovigilance | No Comments

Navigating the Pharmacovigilance Software Maze: Overcoming Implementation Challenges

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays a pivotal role in ensuring drug safety. With the advancement of technology, pharmacovigilance software has emerged as a critical tool for efficiently managing drug safety data. However, the implementation of such software comes with its own set of challenges, ranging from technical hurdles to regulatory compliance issues.

Data Integration Dilemmas

One of the primary challenges faced by organizations when implementing pharmacovigilance software is the integration of diverse data sources. Pharmaceutical companies typically gather data from various channels such as clinical trials, post-market surveillance, and spontaneous reporting systems. Integrating these disparate data sources into a unified platform poses significant technical challenges.

For instance, ensuring the compatibility of different data formats, resolving inconsistencies in data terminology, and overcoming interoperability issues between different systems can be daunting tasks.

How can organizations streamline the process of integrating data from multiple sources into pharmacovigilance software while ensuring data integrity and consistency?

Organizations can employ Extract, Transform, Load (ETL) processes utilizing standardized data formats like E2B (Electronic Transmission of Individual Case Safety Reports) to harmonize and integrate diverse data sources into pharmacovigilance software, ensuring data integrity and consistency.

User Training Trials

Another major hurdle in pharmacovigilance software implementation is providing adequate training to users. Pharmacovigilance professionals, including medical reviewers and safety officers, need to be proficient in using the software to effectively analyze and report adverse events. However, training programs often fall short in providing hands-on experience and practical knowledge. This can result in suboptimal utilization of the software and may compromise the accuracy and timeliness of adverse event reporting.

How can organizations design training programs that cater to the diverse needs of pharmacovigilance professionals and ensure optimal utilization of pharmacovigilance software?

Offer interactive, hands-on training sessions with simulated case scenarios and role-playing exercises tailored to different user roles, complemented by online resources and continuous support channels, ensuring comprehensive skill development and optimal software utilization.

Regulatory Compliance Roadblocks

Ensuring regulatory compliance is perhaps the most critical challenge in pharmacovigilance software implementation. Pharmacovigilance activities are subject to stringent regulations and guidelines imposed by regulatory authorities such as the FDA (Food and Drug Administration) and the EMA (European Medicines Agency). Any deviation from these regulations can have serious consequences, including fines, product recalls, and damage to the company’s reputation.

Regulatory authorities have been increasingly focusing on the use of advanced technologies, including artificial intelligence and machine learning, in pharmacovigilance. This poses additional challenges for organizations in terms of validating these technologies and ensuring their compliance with regulatory standards.

To ensure regulatory compliance, organizations should prioritize thorough validation of pharmacovigilance software, including AI and machine learning components, against relevant regulatory standards like FDA 21 CFR Part 11 and EudraVigilance requirements, while staying abreast of evolving regulatory guidelines.

Scaling Up for Big Data

As the volume and complexity of pharmacovigilance data continue to grow exponentially, organizations face the challenge of scaling up their pharmacovigilance software to handle big data effectively. Traditional pharmacovigilance systems may struggle to process and analyze large datasets in a timely manner, leading to delays in detecting and responding to adverse events. Moreover, storing and managing massive amounts of data require robust infrastructure and advanced data management capabilities, which may be lacking in many organizations.

How can organizations upgrade their pharmacovigilance software infrastructure to accommodate the growing volume of data?

Implement scalable cloud-based solutions leveraging distributed computing architectures such as Hadoop or Spark, alongside advanced database management systems like NoSQL or NewSQL, to handle the increasing volume of pharmacovigilance data efficiently while ensuring scalability and performance.

Interoperability Impediments

Interoperability, or the ability of different systems and software applications to communicate and exchange data seamlessly, is a critical challenge in pharmacovigilance software implementation. Many pharmacovigilance systems operate in silos, making it difficult to share data across departments or with external stakeholders such as regulatory authorities and healthcare providers. Lack of interoperability not only hampers data sharing and collaboration but also increases the risk of data duplication and inconsistency.

The FDA’s Sentinel Initiative, a national electronic system for monitoring the safety of FDA-regulated medical products, emphasizes the importance of interoperability in pharmacovigilance. The initiative aims to create a distributed data network that enables healthcare organizations to share and analyze electronic health data for pharmacovigilance purposes.

How can organizations overcome interoperability challenges and establish seamless data exchange mechanisms between pharmacovigilance software and other healthcare IT systems?

Adopt interoperability standards like HL7 FHIR (Fast Healthcare Interoperability Resources) and implement middleware solutions such as Health Information Exchange (HIE) platforms, facilitating standardized data exchange protocols and seamless integration between pharmacovigilance software and other healthcare IT systems.

Cost Considerations

Implementing pharmacovigilance software involves significant upfront and ongoing costs, which can pose a financial challenge for organizations, particularly smaller companies or healthcare institutions with limited budgets. In addition to the cost of purchasing and licensing the software, organizations need to allocate resources for system customization, integration, training, and maintenance. Moreover, the total cost of ownership may vary depending on factors such as the complexity of the software, the size of the organization, and the level of regulatory compliance required.

How can organizations balance the need for advanced pharmacovigilance software with budgetary constraints and ensure a positive return on investment in terms of improved drug safety outcomes?

Organizations can opt for modular and customizable pharmacovigilance software solutions, leveraging open-source technologies and Software as a Service (SaaS) models to minimize upfront costs and scale resources according to budgetary constraints, while conducting cost-benefit analyses to quantify the impact of improved drug safety outcomes on ROI.

Overcoming Implementation Challenges and Achieving Regulatory Compliance

Navigating the complexities of pharmacovigilance software implementation demands addressing a multitude of challenges from data integration to regulatory compliance and scalability.

Clinevo Technologies, with our expertise in developing and implementing robust technology solutions tailored for the life sciences industry, assists organizations in overcoming these hurdles.

By leveraging our innovative products, such as the OneClinicalTrial Platform and Clinevo Safety, alongside our comprehensive consulting, implementation, and support services, organizations can streamline their pharmacovigilance processes, ensure regulatory compliance, and achieve tangible improvements in drug safety outcomes.

Partner with Clinevo Technologies to navigate the pharmacovigilance software maze effectively and drive success in your pharmacovigilance initiatives.

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By wpclinevouser

Benefits of Implementing Pharmacovigilance Software

May 29, 2024 | Pharmacovigilance | No Comments

Benefits of Implementing Pharmacovigilance Software

Pharmacovigilance stands at the forefront of safeguarding public health by ensuring the safety and efficacy of pharmaceutical products. Did you know that adverse drug reactions are estimated to be the fourth leading cause of death globally?

Pharmacovigilance software is a vital tool, addressing challenges such as manual data entry errors and the overwhelming volume of safety data. From clinical trials to post-marketing surveillance, pharmacovigilance software is indispensable across the drug development lifecycle.

Pharmacovigilance helps in reducing adverse event processing time and enhancing patient safety through early signal detection. As regulations evolve and global collaboration intensifies, the adoption of pharmacovigilance software becomes not just advantageous, but imperative for pharmaceutical companies and regulatory bodies alike.

Why Implement Pharmacovigilance Software?

Implementing pharmacovigilance software offers numerous benefits to pharmaceutical companies, healthcare providers, and regulatory agencies. The global pharmacovigilance market size was valued at $3.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 13.1% from 2021 to 2028. Pharmacovigilance (PV) software helps in the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Here are some key benefits:

Enhanced Safety Monitoring

Enhanced safety monitoring through pharmacovigilance software ensures prompt detection and assessment of adverse events associated with medications. By automating data collection and analysis, these systems expedite the identification of potential safety concerns, allowing for timely intervention to mitigate risks. This proactive approach enhances patient safety, regulatory compliance, and overall public health outcomes. Through advanced analytics and real-time monitoring capabilities, pharmacovigilance software provides a robust framework for optimizing drug safety surveillance.

Efficient Data Management

These software solutions streamline data collection, management, and analysis, reducing the time and resources required for manual processing. This results in more efficient workflows and better utilization of resources. Pharmacovigilance softwares can reduce the time taken for case processing by up to 50%.

Compliance with Regulatory Standards

Pharmacovigilance software ensures compliance with regulatory requirements by facilitating the generation of comprehensive safety reports and submissions to regulatory authorities. This helps companies avoid penalties and maintain their reputation. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently updated its guidelines on pharmacovigilance to align with international standards, emphasizing the importance of robust pharmacovigilance systems.

Early Detection of Safety Signals

Early detection of safety signals in pharmacovigilance software is achieved through advanced signal detection algorithms and data analytics. These algorithms analyze large volumes of adverse event reports and other relevant data sources to identify patterns, trends, and potential safety concerns associated with medications. By utilizing statistical methods and machine learning techniques, pharmacovigilance software can pinpoint emerging risks and safety signals at an early stage, enabling timely intervention and risk mitigation strategies.

Global Collaboration and Knowledge Sharing

Pharmacovigilance software facilitates collaboration among stakeholders across the globe, enabling the exchange of safety data and insights. This fosters a collaborative approach to drug safety and enables faster identification of emerging risks. Initiatives like the VigiBase, World Health Organization’s Global Individual Case Safety Report (ICSR) Repository aim to improve global pharmacovigilance by centralizing safety data and promoting information sharing.

Real-time Monitoring

Pharmacovigilance software enables real-time monitoring of adverse events and safety signals, allowing for immediate action when necessary. This proactive approach reduces the likelihood of serious adverse events occurring and enhances patient safety. Real-time pharmacovigilance systems have been shown to significantly decrease the time between adverse event occurrence and signal detection compared to traditional methods.

Customized Reporting and Analytics

Modern pharmacovigilance software offers customizable reporting and analytics features, allowing users to generate tailored reports based on specific criteria and preferences. This flexibility enables companies to extract meaningful insights from their safety data and make informed decisions regarding risk management strategies.

Integration with Electronic Health Records (EHRs)

Integration of pharmacovigilance software with electronic health record systems enhances data interoperability and facilitates the seamless exchange of patient information between healthcare providers and pharmaceutical companies. This integration streamlines the adverse event reporting process and improves the accuracy of safety assessments. EHR-integrated pharmacovigilance system can lead to a significant reduction in duplicate case reports and improved data quality.

For instance, when a patient experiences an adverse drug reaction recorded in their EHR, the integrated pharmacovigilance software can automatically generate a standardized adverse event report, reducing manual entry errors and ensuring timely safety assessment.

Adaptive Risk Management

Pharmacovigilance software supports adaptive risk management strategies by enabling continuous monitoring of drug safety profiles and facilitating timely updates to risk minimization measures. This dynamic approach allows companies to adapt to changing regulatory requirements and evolving safety concerns more effectively. The European Medicines Agency (EMA) ’s concept of adaptive licensing emphasizes the importance of continuous monitoring and risk management throughout a product’s lifecycle which pharamacovigillence software seamlessly enables healthcare personnel with.

Predictive Analytics and Artificial Intelligence (AI)

The integration of predictive analytics and AI algorithms in pharmacovigilance software enhances the capability to identify potential safety issues before they escalate into serious problems. These advanced technologies can analyze large volumes of structured and unstructured data to detect emerging safety signals and trends, enabling proactive risk mitigation strategies. Recent studies highlight how AI-driven pharmacovigilance systems can revolutionize drug safety surveillance and improve patient outcomes.

Enhanced Transparency and Public Trust

By providing transparent access to safety data and regulatory decisions, pharmacovigilance software fosters public trust in the pharmaceutical industry and regulatory agencies. Increased transparency promotes greater accountability and confidence among stakeholders, leading to improved collaboration and communication regarding drug safety issues. Initiatives such as the FDA’s OpenFDA platform and the European Union’s EudraVigilance database aim to enhance transparency in pharmacovigilance and support evidence-based decision-making.

Optimizing Pharmacovigilance Through Integrated Software Solutions

Integrating pharmacovigilance software with electronic health record systems facilitates seamless data exchange, streamlines adverse event reporting, and enhances safety assessments.

Clinevo Technologies specializes in developing and implementing robust technology solutions for life sciences R&D, including pharmacovigilance software integrated with electronic health records. By leveraging our expertise and innovative solutions, stakeholders can ensure compliance, improve efficiency, and contribute to better healthcare outcomes globally.

Contact us today to learn more about how we can help optimize pharmacovigilance processes and enhance patient safety.

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By wpclinevouser

Features and Functions of Pharmacovigilance Software

April 24, 2024 | Pharmacovigilance | No Comments

Features and Functions of Pharmacovigilance Software

Pharmacovigilance software stands as a cornerstone in ensuring the safety and efficacy of pharmaceutical products. With its array of features and functionalities, pharmacovigilance software empowers healthcare professionals to monitor, analyze, and manage drug safety data effectively. Let’s delve into a detailed exploration of the key features and functions that pharmacovigilance software offers, ranging from adverse event reporting to compliance tracking.

I. Adverse Event Reporting

Adverse event reporting is at the core of pharmacovigilance software, allowing healthcare professionals to capture and document adverse events associated with pharmaceutical products. Key features in this area include:

  • User-Friendly Interface: Intuitive interfaces streamline the adverse event reporting process, guiding users through data entry fields and ensuring completeness and accuracy in reporting.
  • Customizable Forms: Pharmacovigilance software offers customizable reporting forms to accommodate various types of adverse events and capture relevant information, such as patient demographics, medical history, and drug details.
  • Integration with Data Sources: Seamless integration with electronic health records (EHRs), clinical trial management systems (CTMS), and other data sources enables automatic data capture, reducing manual entry errors and enhancing efficiency.

II. Signal Detection

Signal detection capabilities enable pharmacovigilance software to identify potential safety issues and emerging trends in adverse event data. Key features in this area include:

  • Advanced Analytics: Sophisticated data analytics tools, including statistical algorithms and machine learning models, analyze adverse event data to detect patterns, clusters, and associations that may indicate safety signals.
  • Risk Assessment Tools: Pharmacovigilance software provides risk assessment tools to evaluate the significance and severity of identified signals, helping healthcare professionals prioritize further investigation and risk mitigation efforts.
  • Real-Time Monitoring: Real-time monitoring capabilities enable continuous surveillance of safety data, allowing for prompt detection and response to emerging safety concerns.

III. Risk Management

Effective risk management is essential in mitigating potential risks associated with pharmaceutical products. Pharmacovigilance software offers a range of features to support risk management efforts, including:

  • Risk Evaluation and Mitigation Strategies (REMS): Pharmacovigilance software facilitates the development and implementation of REMS programs, including risk communication plans, medication guides, and restricted distribution systems, to minimize patient exposure to known or potential risks.
  • Safety Profile Management: Comprehensive safety profile management tools enable healthcare professionals to monitor and update the safety profiles of pharmaceutical products based on emerging safety data and regulatory requirements.
  • Adaptive Risk Management: Adaptive risk management features allow for iterative risk assessment and modification of risk management strategies based on evolving safety data and regulatory feedback.

IV. Compliance Tracking

Ensuring compliance with regulatory requirements is paramount in pharmacovigilance. Pharmacovigilance software offers robust compliance tracking features to facilitate adherence to regulatory standards and guidelines, including:

  • Regulatory Reporting Automation: Automated regulatory reporting functionalities streamline the submission of safety reports to regulatory authorities, ensuring timely compliance with reporting deadlines and requirements.
  • Audit Trail Documentation: Comprehensive audit trail documentation capabilities track changes made to safety data, ensuring transparency and accountability in pharmacovigilance activities and regulatory submissions.
  • Compliance Monitoring Dashboard: Compliance monitoring dashboards provide real-time visibility into pharmacovigilance performance metrics, allowing healthcare professionals to identify areas of non-compliance and take corrective actions as needed.

V. Reporting and Analytics

Comprehensive reporting and analytics capabilities empower healthcare professionals to derive actionable insights from pharmacovigilance data. Key features in this area include:

  • Customizable Reporting Templates: Pharmacovigilance software offers customizable reporting templates to generate standardized safety reports for internal stakeholders, regulatory authorities, and other stakeholders.
  • Interactive Data Visualization: Interactive data visualization tools, such as dashboards and heatmaps, enable healthcare professionals to visualize and explore safety data trends, patterns, and outliers, facilitating data-driven decision-making.
  • Trend Analysis and Forecasting: Trend analysis and forecasting functionalities allow healthcare professionals to identify long-term safety trends and anticipate future safety risks, enabling proactive risk management strategies and interventions.

VI. Data Management and Integration

Pharmacovigilance software often needs to integrate seamlessly with various systems and processes within a pharmaceutical company’s infrastructure to ensure efficient operations and data flow. Integration enables data sharing, streamlines workflows, and enhances overall pharmacovigilance activities.

Pharmacovigilance software may need to integrate with:

Clinical Trial Management Systems (CTMS): Integration with CTMS allows for the seamless transfer of adverse event data collected during clinical trials into the pharmacovigilance system. This ensures that safety data is promptly captured and analyzed throughout the drug development process.

Electronic Health Record (EHR) Systems: Integration with EHR systems enables pharmacovigilance professionals to access patient medical records and history, facilitating comprehensive evaluation of adverse events and potential drug-related issues.

Drug Safety Databases: Integration with internal drug safety databases ensures that adverse event data collected from various sources, such as clinical trials, post-marketing surveillance, and spontaneous reporting systems, are consolidated and managed efficiently within the pharmacovigilance system.

Regulatory Reporting Systems: Integration with regulatory reporting systems allows for automated submission of safety reports to regulatory authorities, ensuring compliance with regulatory requirements and deadlines.

Data Analytics Platforms: Integration with data analytics platforms enhances the capability of pharmacovigilance software to analyze large datasets and identify safety signals and trends, thereby supporting informed decision-making and risk assessment.

Overall, integration with these systems within a pharmaceutical company’s infrastructure ensures that pharmacovigilance software operates seamlessly within existing workflows, maximizes efficiency, and facilitates effective management of drug safety data throughout the product lifecycle.

Conclusion

Pharmacovigilance software plays a critical role in ensuring drug safety and protecting public health. With the growth of technology and data, the integration of pharmacovigilance software with various systems has become crucial for efficient management of drug safety data. This integration enables seamless capture, analysis, and reporting of adverse event data from various sources throughout the product life cycle, promoting effective risk management and enabling timely decision-making.

As the pharmaceutical industry continues to evolve, the integration of pharmacovigilance software with internal drug safety databases, regulatory reporting systems, and data analytics platforms will become even more vital for ensuring the safety of medicines. It is essential for pharmaceutical companies to prioritize the integration of pharmacovigilance software to effectively manage drug safety and ensure compliance with regulatory requirements.

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By wpclinevouser

Introduction to Pharmacovigilance Software

April 24, 2024 | Pharmacovigilance | No Comments

Introduction to Pharmacovigilance Software: An Overview

In the dynamic landscape of the healthcare industry, ensuring the safety and efficacy of pharmaceutical products remains paramount. Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays a pivotal role in achieving this objective.

At the heart of pharmacovigilance lies sophisticated software solutions designed to streamline and enhance the monitoring process. Let’s delve into the realm of pharmacovigilance software, exploring its definition, evolution, and its significant role in the pharmaceutical industry.

Understanding Pharmacovigilance Software

Definition and Scope

  1. What is Pharmacovigilance Software?
    Pharmacovigilance software encompasses a suite of tools and technologies aimed at facilitating the collection, analysis, and management of data pertaining to drug safety. These software solutions are tailored to meet the specific needs of pharmacovigilance professionals, offering functionalities for adverse event reporting, signal detection, risk assessment, and regulatory compliance.
  2. Scope of Pharmacovigilance Software Applications
    With the rising mandate for pharmacovigilance across the globe, there has been a significant shift towards using advanced software systems. These solutions are widely used in different stages of drug development, including pre-marketing surveillance, post-marketing surveillance, and clinical trials.

Evolution of Pharmacovigilance Software

Early Days: Manual Methods and Paper-Based Systems

The journey towards modern pharmacovigilance software can be traced back to the early 1970s when manual systems were used for reporting adverse events. With the increasing complexity of drug safety data, there was a need for more efficient and advanced tools. This led to the development of electronic databases in the 1980s and eventually, web-based systems in the 1990s.

Transition to Digital Solutions

With the advent of digital technology, pharmacovigilance software began to emerge as a more efficient alternative to manual methods. Basic digital solutions facilitated the electronic collection and storage of adverse event data, offering greater convenience and accuracy compared to paper-based systems. However, these early digital solutions were limited in functionality and lacked the advanced features of modern pharmacovigilance software.

Technological Advancements: Automation and Data Analytics

As technology continued to advance, pharmacovigilance software underwent significant improvements in functionality and capability. Automation became a key feature, streamlining processes such as adverse event reporting and data entry. Furthermore, the integration of data analytics tools enabled pharmacovigilance professionals to analyze large datasets more efficiently, identifying potential safety issues and trends with greater accuracy.

Today, pharmacovigilance software has evolved into sophisticated, cloud-based solutions with a wide range of features and capabilities. These include real-time data collection, automated signal detection, risk management workflows, integration with other healthcare systems, and more.

Is Pharmacovigilance Software Required?

A simple answer is yes, pharmacovigilance software is important for effective drug safety monitoring. With the increasing complexity and global reach of pharmaceutical products, manual methods are no longer sufficient to keep up with the volume and speed of adverse event reporting.

Regulatory Mandates:

  • Regulatory authorities such as the FDA and EMA mandate the implementation of pharmacovigilance systems by pharmaceutical companies.
  • Compliance with regulatory requirements necessitates the use of pharmacovigilance software for timely adverse event reporting and regulatory submissions.

Complexity of Data Management:

  • The volume and complexity of adverse event data generated during clinical trials and post-marketing surveillance make manual data management impractical.
  • Pharmacovigilance software provides the necessary tools to streamline data collection, analysis, and reporting, ensuring accuracy and efficiency in pharmacovigilance processes.

Risk Mitigation:

  • Failure to detect and address safety issues promptly can lead to significant risks to patient health and regulatory non-compliance.
  • Pharmacovigilance software facilitates early detection of adverse events, enabling proactive risk mitigation strategies to safeguard patient safety and regulatory compliance.

Enhanced Efficiency:

  • Manual pharmacovigilance processes are labor-intensive and prone to errors, leading to inefficiencies and delays in adverse event reporting.
  • Pharmacovigilance software automates repetitive tasks, improves data accuracy, and enhances workflow efficiency, enabling pharmacovigilance professionals to focus on critical tasks such as signal detection and risk assessment.

Role of Pharmacovigilance Software in Patient Safety

Pharmacovigilance software plays a crucial role in ensuring patient safety throughout the drug development and post-marketing process. By facilitating early detection of adverse events, automating manual processes, and enhancing efficiency, pharmacovigilance software helps to safeguard patient health and reduce risks associated with pharmaceutical products. With its ever-evolving capabilities, pharmacovigilance software continues to be a vital tool in promoting patient safety and improving drug development processes

Role of Pharmacovigilance Software in Patient Safety

Early Detection of Adverse Events

Pharmacovigilance software enables early detection of adverse events by automating the collection, analysis, and monitoring of safety data from various sources. This proactive approach allows healthcare professionals to identify potential safety concerns promptly and take appropriate actions to mitigate risks to patient health.

Automating Manual Processes

By automating manual processes such as adverse event reporting and data entry, pharmacovigilance software minimizes the risk of human error and ensures data accuracy. This streamlines pharmacovigilance activities, allowing pharmacovigilance professionals to focus their time and resources on critical tasks such as signal detection and risk assessment.

Promoting Continuous Improvement

Pharmacovigilance software supports continuous improvement in drug safety monitoring by providing tools for data analysis, trend identification, and risk assessment. By analyzing safety data trends over time, pharmacovigilance professionals can identify areas for improvement in drug development processes, product labeling, and risk management strategies, ultimately enhancing patient safety and the quality of healthcare delivery.

Facilitating Collaboration and Communication

Pharmacovigilance software facilitates collaboration and communication among healthcare professionals, regulatory authorities, and other stakeholders involved in drug safety monitoring. By providing centralized access to safety data and enabling secure communication channels, pharmacovigilance software promotes collaboration in safety assessment, risk management, and decision-making, ensuring a coordinated and proactive approach to patient safety.

Conclusion

With its essential role in the pharmaceutical industry, it is crucial for companies to invest in high-quality pharmacovigilance software and continually update their systems to stay compliant with regulatory requirements and industry best practices. As technology continues to advance, we can expect pharmacovigilance software to evolve as well, incorporating more sophisticated features and capabilities to further enhance its efficacy in managing drug safety data.

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By wpclinevouser

What is Pharmacovigilance and Why is It Super Important

February 29, 2024 | Pharmacovigilance | No Comments

Medicines and vaccines are remarkable tools for improving health and saving lives. Yet, even with rigorous testing, they’re not without potential risks. That’s why we need pharmacovigilance.

Hold up, what’s with this “pharmacovigilance” jargon? Think of it as the science of keeping tabs on meds and vaccines, making sure they’re doing their job without any nasty surprises.

Why Not Stop With Just Clinical Testing 

While clinical trials play a vital role in assessing safety and efficacy, they have limitations. They involve a relatively small group of participants and a restricted time frame. This means that rare or longer-term side effects might not be identified until the medicine or vaccine is used by a larger, diverse population over a longer period. This is why we need to know the importance of pharmacovigilance.

Continuous Monitoring: 

Pharmacovigilance isn’t a one-time event; it’s an ongoing process. Once approved, medicines and vaccines are continuously monitored to ensure their continued safety and effectiveness. This involves several key players:

Patients:

  • Report any side effects you experience: Even if unsure if the medicine caused them, reporting helps build a comprehensive picture of potential risks.
  • Read the package insert: This information leaflet provides details about known side effects and helps patients understand what to watch out for.

Healthcare Professionals:

  • Report any side effects observed in your patients: This includes both confirmed and suspected reactions.
  • Share relevant information with patients: Help them understand the importance of reporting and how to do so effectively.

Market Authorization Holders (Pharmaceutical Companies):

  • Proactively monitor and report side effects: As the product developers, they have a crucial responsibility to track and report any safety concerns.
  • Collaborate with regulatory agencies and healthcare professionals: Sharing data and insights is essential for understanding and addressing potential risks.

What to Report

The information leaflet accompanying any medicine provides details on potential side effects. 

However, it’s important to report any unexpected reactions, especially:

  • Serious Adverse Reactions: Any effect that results in death, life-threatening conditions, prolonged hospitalization, disability, or other serious medical events.
  • New Medicines and Vaccines: Any reactions observed with recently introduced products.
  • Medication Errors: Cases where the wrong medicine, dose, or administration route was used, leading to serious harm.
  • Lack of Efficacy: If the medicine seems ineffective in its intended purpose.
  • Overdose and Off-Label Use: Any serious reactions resulting from taking more than the recommended dose or using the medicine for a purpose not approved by regulatory authorities.
  • Suspected Product Defects: If you believe the product itself might be faulty and causing adverse reactions.

What constitutes “serious”?

  • Death
  • Life-threatening situations
  • Hospitalization or extended stays
  • Permanent disabilities or birth defects
  • Other critical medical interventions

Importance of Pharmacovigilance in Identifying and Documenting Adverse Reactions

1.Reporting as a Patient:

As a patient or caregiver, you witness firsthand how a particular medicine or vaccine impacts your health. If you experience any unexpected symptoms or changes in your well-being after taking a medication or receiving a vaccine, don’t hesitate to report it. Even seemingly minor side effects can provide valuable insights.

Why Report as a Patient?

Every report you submit contributes to a larger network of information, making medicines and vaccines safer for everyone. While extensive testing happens before these products become available, unexpected side effects sometimes emerge when used by a wider population. Your report could

  • Identify previously unknown or uncommon side effects.
  • Lead to updates in product information or labeling to better inform users.
  • Prompt regulatory actions like product recalls or adjustments if necessary.
  • Contribute to international data analysis, leading to improved understanding of overall benefits and risks.

How to Report as a Patient:

  • Talk to your doctor or pharmacist: They are best equipped to assess your symptoms and understand potential connections to the medication or vaccine.
  • Use online reporting systems: Many countries have user-friendly online platforms for reporting side effects. For example, in India, you can use the Pharmacovigilance Programme of India (PvPI) portal.
  • Contact your national regulatory agency: Most countries have specialized agencies responsible for monitoring drug safety. They might have alternative reporting channels for patient use.

2.Reporting as Healthcare Professionals 

Doctors, nurses, and pharmacists play a critical role in identifying and reporting side effects. Your expertise in patient care and understanding of medications makes your reports invaluable.

Why Report as a Healthcare Professional?

You see a wider range of patients and potential reactions than individual patients do. By reporting, you

  • Contribute to a more comprehensive picture of medication and vaccine safety.
  • Help identify trends and patterns that might otherwise go unnoticed.
  • Assist in ensuring the best possible care for your patients and future generations.

How to Report as a Healthcare Professional

  • Use established reporting systems: Most countries have dedicated healthcare professional portals for reporting side effects. These portals often offer additional resources and guidance.
  • Follow your national regulations: Many countries mandate healthcare professionals to report specific types of side effects. Familiarize yourself with your obligations.
  • Encourage patient reporting: Educate your patients about the importance of reporting side effects and provide them with easy access to reporting channels.

3.Reporting as Pharmaceutical Industry

Pharmaceutical companies have a primary responsibility to ensure the safety of their products. This includes actively monitoring and reporting adverse events.

Why Report as a Pharmaceutical Company?

  • Proactive reporting demonstrates your commitment to product safety and transparency.
  • Early identification of potential issues allows for swift corrective actions, minimizing harm to patients.
  • Your data contributes to the broader understanding of medication and vaccine safety, benefiting the entire industry.

How to Report as a Pharmaceutical Company

  • Follow regulatory requirements: Each country has specific regulations for reporting adverse events by pharmaceutical companies. Adherence is crucial.
  • Maintain robust internal reporting systems: Ensure your company has efficient mechanisms for collecting, analyzing, and reporting data on adverse events.

Collaborate with regulatory agencies: Work openly and transparently with regulators to facilitate effective monitoring and safety measures.

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By wpclinevouser

10 Essential Features of a Modern Pharmacovigilance Database

July 20, 2020 | Pharmacovigilance | No Comments

Pharmacovigilance has grown significantly in recent years and its importance in the healthcare sector has been recognized worldwide. To prevent or lower the patient hazards, improvements in public health and precise evaluation and monitoring of drug safety has become extremely important. This makes the need for a highly efficient Pharmacovigilance (PV) database essential for all the Pharma, Biotech, and Clinical Research Organizations.

Being a highly essential system in the life sciences sector, a PV database should be able to achieve maximum productivity at the same time keeping track of compliance where the humans can fail to complete the processes with accuracy and efficiency.

To obtain this kind of productivity and efficiency, you must keep in mind some of the essential features which a PV system should comprise.

1. The Must-Have Basic Features:

Below are some essential features that a pharmacovigilance database should have:

  • The system should have the ability to report adverse events via configurable web form over secured internet.
  • Custom validation should be present to ensure data consistency & completeness of cases.
  • ICSRs – R2 & R3 compliance.
  • Periodic Reports (like NDA, PADER, PSUR, etc.) and Line listings must be present.
  • Must have an automated configuration for listedness.
  • Auto narratives.
  • Should support medical devices, clinical studies, spontaneous, literature cases, etc.
  • MedDRA and WHO Drug dictionary integration
  • The system should have more configurations and less customizations
  • Must have an in-built AS2 gateway for regulatory e-submissions.

2. User Friendly and Easy-to-Use:

When a company adopts a new technology, sometimes it makes a mistake of neglecting the usability and user friendliness. It is critical to address this for the success of high-performing PV business. This should never be overlooked.

Good usability can improve the performance and result in easy and faster case processing and submissions. It can boost profitability or ROI of your PV business. Training new team members and adopting new processes becomes much easier with the easy to use and user-friendly applications.

A PV database with a lot of advanced features without a user-friendly interface will gradually reduce the performance and the interest of the team and gradually impacts the timelines and the overall business.

3. Configurable to meet sponsor SOPs

The timelines of submission differ for each regulatory agency and sponsors. The SOPs differs from sponsor to sponsor. A PV database should be dynamic enough to be confirmed to address all the changing regulatory and sponsor needs with configurations. The system should not make the sponsor to change his SOP according to the system, but the system should be capable of meeting sponsor SOP and timelines.

Example:

The system should provide dynamic workflows to create different workflows for different types of cases (serious cases vs. non-serious vs. death cases). A company should be able to configure different timelines and different QC/MR process for a serious case and death case.

For a serious case, the admin should be able to set the duration of the complete process as 5 days – set 2 days for the completion of Data Entry, 1 day each for the other three processes, whereas he can set a 15-day duration for a non-serious case and can assign 4 days for Data Entry, 4 days for Quality Review, 4 days for Medical Review, 3 days for Reporting or whatever sequence he requires. Similarly, he can assign the 4 days to the serious and death cases giving 1 day each for every process and so on.

4. Automated Case Tracking / Monitoring Case Submission Timelines

Meeting timelines of the regulatory compliance is a crucial task in Pharmacovigilance. When the number of cases increases, it becomes hard for the CROs/ Pharma companies to track every case to ensure it is processed and submitted to agencies on time.

PV database should be capable of assigning timelines for the cases based on the sponsor / regulatory timelines and track the cases to ensure it is submitted to regulatory agencies on time. The feature should allow the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case has not been dealt with within the required time period.

5. Regulatory Compliance and Inspection Ready

The system should maintain an audit trail for every operation. It should have fully-compliant eSignatures for all stakeholders. Pharmacovigilance database should comply with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GDPR, GxP, GAMP5 guidelines, etc.

System should comply with global regulations and reports and output formats supported by global regulatory agencies.

The system should also have inbuilt Audit Reports which can be given to auditors during the PV system audits which should give complete audit and necessary information required for easy audits

6. Should be Cost-Effective:

Pharmacovigilance is an expense for any company. Some Pharma/CROs on the verge of saving costs, they cut the costs on the teams they hire, and they spend a lot on procuring traditional Pharmacovigilance databases. This strategy is completely wrong. Just an expensive PV system cannot meet all the regulatory guidelines without a strong team in place.

Pharmacovigilance requires strong quality reviewers, medical reviews and case processers. Pharmacovigilance team is very crucial to any company. Hence companies should spend their PV budget in getting strong and right team in place and focus on reducing the PV budget by choosing a cost-effective PV system.

The technological advancements provide rapid application development options to the software companies who can develop end-to-end PV platform in a short duration and with a small budget. Traditional expensive systems are not really required when a cost-effective Pharmacovigilance database can meet all the regulatory requirements.

7. Website and Call Centre ADRs / MI / PQCs

With the changing regulatory guidelines and increasing regulations, it is important to completely get rid of any information that is tracked out of the Pharmacovigilance databases.

ADRs are generally completely processed and tracked in the Pharmacovigilance database. But most of the PV databases does not support capturing and tracking of the medical inquiries and product quality complaints. Since the MI, PQCs and ADRs goes hand in hand, the Pharmacovigilance database should support handling of MIs and PQCs as well. Pharmacovigilance database should also support receiving the ADRs, MIs and PQCs directly from the Sponsor websites and Sponsor / CRO call centres.

8. AI & Automation

The future is going to be Automation and AI. There are a lot of advancements going on in Pharmacovigilance using Automation and AI. Though there are no solid proven AI capabilities in the PV, the Pharmacovigilance database should have AI and Automation capabilities with which some of the processes like Literature Screening, Social media searches etc. can be automated. The system should be mandatorily built with the framework with supports AI and Automations.

9. Multilingual Capabilities

There is a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / Pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.

For countries like Japan and China, new rules for Pharmacovigilance are on the way. CROs, Biotech and Pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.

Multilingual system would also be of great use as the local Pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.

Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world hence the Pharmacovigilance database should be multilingual.

10. Signal Detection

As manual signal detection processes consume considerable time, PV team might require a few weeks to analyse a signal. The system should have an in-built signal detection feature as the PV team require focusing on real-time issues while reducing the time and effort spent in determining the fake signals. Hence it is important that the PV database supports signal detection.

Hope you found this article informative. Please reach out to prasanna.g@clinevotech.com, if you have any comments.

 

 

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By Prasanna Gurumoorthy

Achieving Multilingualism in Pharmacovigilance with a Cost-Effective Solution

February 24, 2020 | Pharmacovigilance | No Comments

Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pharmacovigilance being an extensive part of healthcare and clinical trials requires the combination of deep understanding of medical translation with the intricacies of clinical research, marketing and reporting. Some countries have made the reporting in their local language mandatory.

The Need for Multilingualism in Pharmacovigilance

There’s a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.

For countries like Japan and China, new rules for pharmacovigilance are on the way. CROs, biotech and pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.

Multilingual system would also be of great use as the local pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.

Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world.

Clinevo Safety & It’s Multilingual Capabilities

Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end to end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case processing, Regulatory submissions / AS2 gateway, Analytics, and Safety signals capabilities under one platform.

It is supported by technology that enables quick turnaround of your specialist requirements. Clinevo Safety can process data in any language like German, Japanese, Chinese, etc. The complete system gets adopted to any language with just an admin configuration.

Apart from just multilingual capabilities, Clinevo Safety also offers dual language support where all the text is available in two different languages and these languages can be set according to the user preference. The multilingual and dual language capability of Clinevo Safety makes it a language friendly, efficient and cost-effective multilingual global system.

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By wpclinevouser

Clinevo Technologies & Galaxi Consulting partners to reduce 75% IT cost in Pharmacovigilance, Clinical Data Warehousing and Automation Solutions in the Europe market

September 5, 2019 | Clinical Data Warehouse, Pharmacovigilance | No Comments

Galaxi Consulting is a leading Life Sciences and Manufacturing consulting firm focused on finding the best solutions for Pharma and Biotech clients across Europe and the UK, currently working with the Fortune 100 Pharmaceutical and Healthcare companies. They are also digital recruiters specialized in sourcing and deploying the topmost applicants in the Life Sciences, Biotech, Pharma and Manufacturing sector.

Clinevo Technologies is a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. They help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involve Data Warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence.

Clinevo Technologies currently has 3 products on a GxP Cloud:

Clinevo Safety: Clinevo Safety is a cloud based, easy to use, regulatory Compliant, AI enabled, end-to-end Pharmacovigilance / Drug Safety system. This all-in-one system provides PV Intake, Case processing, AI, Analytics, Submissions/AS2 gateway and Safety signals capabilities under one platform.

Clinevo DW and Automation: Clinevo Data Warehousing and Business Process Automation Console is a secured, regulatory compliant Clinical Trials Data Warehouse to Acquire, Store, Transform, Consolidate and Report diverse data from clinical trials in one place and AUTOMATE any of the manual, cumbersome business processes. This platform can enable companies to perform Cross Study Analysis, Data mining, Predictive Analytics, etc.

Clinevo eTMF: Clinevo eTMF is an extendable electronic trial master file in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.

The Partnership:

Clinevo and Galaxi Consulting are pleased to announce a partnership that extends the power of Clinevo’s innovative cloud-based technology solutions and Galaxi Consulting’s international talent pool of Life Sciences specialists and aimed at helping Pharmaceutical, Biotech and CROs with high performing, GxP compliant Pharmacovigilance and Clinical trial solutions.

This partnership is primarily aimed at cutting down the IT cost in the Life Sciences R&D domain by 75% with unique cloud-based IT solutions.

Arunkumar Devaraj, Director of Life Sciences at Clinevo, said, “We have developed a lot of unique features that would make our products as the best when compared to other existing products in the market. We already have a lot of highly satisfied customers from USA and India market and we are excited to be partnering with Galaxi Consulting and introducing our products to its customers in Europe and the UK”.

Gaurav Sharma, Director, Galaxi Consulting said, “We are highly impressed with the Clinevo’s end-to-end product strategy which brings in a lot of benefits with huge cost savings to the customers who are into Pharmacovigilance and Clinical Trials. With our vast consulting experience in Europe and the UK, we are looking forward to delivering high-quality solutions to the customers”.

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By wpclinevouser

Improving Compliance and Productivity in Pharmacovigilance using Robotic Process Automation based Workflows

August 22, 2019 | Pharmacovigilance | No Comments

Pharma, Biotech, CRO and Life Sciences companies have pharmacovigilance as a mandatory regulatory responsibility. As there’s an exponential increase with the volume of Individual Case Safety Reports (ICSR) increasing every year it has become quite mandatory to design an automated solution for the largely manual pharmacovigilance process for these companies.

What is Robotic Process Automation?

Robotic process automation is one of the emerging forms of business process automation technology based on the notion of metaphorical software robots or artificial intelligence.

The current wave of automation in the pharmacovigilance industry usually refers to Robotics also known as RPA (Robotic Process Automation), where the repetitive manual steps can be automated and no human intervention is required. Repetitive tasks performed by the robotic process can remarkably help in reducing the dependency on humans with a direct increase in efficiency and also improvement in overall quality, productivity and compliance.

About Clinevo Safety

Clinevo Safety is a cloud-based, user-friendly, easy to use, regulatory compliant, end-to-end Pharmacovigilance / Drug Safety System. This all-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals Capabilities under one platform.

Robotic Process Automation in Clinevo Safety

Clinevo Safety has been designed with regards to the robotic process automation automating some of the key process to achieve maximum productivity at the same time keeping track of compliance where the humans can fail to complete the processes with accuracy and efficiency.

Below are some of the key features of Clinevo Safety which uses RPA based automation:

1. RPA based Dynamic Workflows – Prioritizes the cases based on seriousness

Traditional standard workflows:

In the traditional PV system, the workflow is completely fixed where for the entire organization and for all the scenarios the workflow is going to be standard. Be it a serious case, non-serious case, etc., the workflow is going to be exactly the same.

For Example: The admin will only be able to set a fixed time period of up to 15 days or less for every type of case making every process completion utilizing the same amount of time irrespective of the seriousness of the case. This will make the process slower and inefficient.

 

Dynamic workflows:

Clinevo Safety provides RPA based dynamic workflow to create different workflows for different types of cases. The feature enables the time period to be easily changed for all the cases and not lock them into a specific schema.

For example: For a serious case, the admin can set the duration of the complete process as 5 days and set 2 day for the completion of Data Entry and 1 day each for the other three processes, whereas he can set a 15 day duration for a non-serious case and can assign 4 days for Data Entry, 4 days for Quality Review, 4 days for Medical Review, 3 days for Reporting or whatever sequence he requires. Similarly, he can assign the 4 days to the serious and death cases giving 1 day each for every process and so on.

Based on the setup by the administrator, the system will automatically determine which workflow has to be followed for any case and performs the case assignment automatically. Hence Prioritizing the cases on its serious is completely automated.

2. Robotic Workload Balancer

Usually the case assignments are manual where there is a need of a workflow manager who has to determine the complete load of every individual manually and assign the cases. Sometimes, he has to wait for someone to take up a case from the respective group.

Along with the manual case assignment option, Clinevo Safety provides an Automated Workflow Manager which enables the system to determine the workload of every individual and assigns the cases to them based on their availability, current workload and capacity by examining their history of case handling.

If the bandwidth of the team is completely utilized and the system determines that the case cannot be processed on time, it triggers alerts to the reporting managers for taking the case on manual assignment mode .

3. Robotic Case Monitor

Clinevo Safety has a RPA based monitor for monitoring and reporting (sending auto-notifications) to the process groups/ workflow manager/ head of the department whenever there is any pending case from any group performing the processes is observed.

The feature allows the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case hasn’t been dealt with within the required time period. The feature also escalates the issue to the person in charge of the pharmacovigilance of that company. It ensures you don’t fail to complete any case due to uninformative reasons.

4. Automated Traffic-Light Color Coding

The PV system also comprises of automated traffic-light color-coding for providing an intimation about the status of any case.

There are three colors visible in front of every case. Green is referred to a case that is processed right on time, Yellow is for a case that is nearing its due date and Red is for a case that is already overdue and is yet to be processed.

The color coding makes it easier for the users as well as the administrator of the system to have knowledge about the status of their cases and help in a timely procession of each case.

The list of the color-coded cases is visible on a highly interactive customizable dashboard which makes the system excessively user-friendly. This list enables the users to be well aware of the status of every case they’re handling.

5. Automated Daily Report Generation

The system also has the ability to generate daily status reports on an everyday basis. The report provides an overview about the status of every case at each processing phase.

The status of the cases is available on the interactive dashboard. It also generates automated notifications in the form of emails which consists of information regarding the same. The report helps the users as well as other concerned personnel to stay updated about every case and the process it’s going through.

Conclusion

In comparison to the existing systems in the market, Clinevo Safety has the following features which are enabled by RPA:

1. Clinevo Safety is prioritizing the cases (serious cases) that have to be taken over before the other cases (non-serious cases).
2. Automatic workload balancer will ensure the work is shared among people and high productivity is achieved.
3. It automatically sets the due dates for all the cases and their processes and sends automated follow-ups keeping you updated about the status of every case.
4. It also sends automated alerts to the concerned person when there has been no action taken for a certain case when it is nearing its due date.
5. Overall, it tracks all cases ensuring that none of the cases are gone out of hand and are efficiently processed on time.

Thus, the application of RPA features in Clinevo Safety makes it a highly productive, reliable and efficient PV system resulting to improved compliance and productivity in pharmacovigilance.

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By wpclinevouser

Pharmacovigilance in India

August 14, 2019 | Pharmacovigilance | 2 Comments

Author: Arunkumar Devaraj, Director of Products and Solutions, Clinevo Technologies.

Date: 17-Jul-2019

The Indian Pharmacopeia Commission published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which was effective January 2018. The new guidance is heavily influenced by USFDA and EMA Pharmacovigilance regulations.

According to the guidelines: “MAHs are required to collect and process comprehensive safety information related to pharmaceutical products and reports to the regulatory authority within the prescribed timelines. Every MAH shall have a system in place that ensures the overall quality of AEs/ADRs.” Term “MAH” refers to the manufacturer or importer of the drug, who has a valid manufacturing or import license in India”.

According to the guidelines, below are the 6 key components that a Pharmacovigilance department of a MAH should consist of:

1. Pharmacovigilance System Master File (PvMF) & Pharmacovigilance Officer In-charge (PvOI):

  • PvMF: (similar to the pharmacovigilance system master file PSMF) must contain all the information related to the MAH’s PV system, including the PV Officer In-charge (PvOI), PV organization structure, sources of safety data, PV processes and PV systems.
  • PvOI: PvOI shall have sufficient authority over the pharmacovigilance system and be responsible for compliance. The PvOI is mandated to be a Medical Officer or a Pharmacist trained in the collection and analysis of Adverse Drug Reaction (ADR) reports.

2. ICSRs and Pharmacovigilance Database (Software):

A Pharmacovigilance database may be required to do the mandated activities mentioned below:

  1. MAH must collect and report Individual Case Safety Reports (ICSRs), from different sources.
  2. Monthly literature review using electronic literature database is required.
  3. Screening of medical inquiries, internet/digital media, solicited reports, special populations is required.
  4. The MAH is required to code ADRs using a dictionary.

Importantly all ICSRs received by MAHs are mandated to be submitted to PvPI in XML-E2B format.

3. PSURs – Periodic Safety Update Reports (PSURs):

PSURs shall be submitted every six months for the first two years after approval of the drug and annually for the subsequent two years unless extended by the licensing authority in the interest of public health. PSURs due must be submitted within 30 calendar days of the last day of the reporting period.

4. QMS – Quality Management System:

QMS must be in place to monitor the quality cycle of the pharmacovigilance system, quality objectives for pharmacovigilance, responsibilities of the quality system, training of MAH personnel, and required facilities and equipment, with special emphasis on compliance management, record management, documentation of the quality system, and critical pharmacovigilance processes.

5. PV audits and inspections should be conducted both internally and externally to the PV systems.

6. RMPs: Risk Management Plans, including the objectives, their content and risk minimization activities, and highlights specific pharmacovigilance activities must be in place. The general understanding is that an RMP must be submitted at the time of product approval and/or upon request by the competent authorities, although it is not explicitly mentioned in the guidelines.

Although complying with the pharmacovigilance requirements pronounced by this guideline may be quite challenging there are provisions for outsourcing most of its mandated activities to Pharmacovigilance vendors. With India serving as the global capital of pharmacovigilance outsourcing today, MAHs may make use of these provisions and quickly augment their Pharmacovigilance systems by choosing appropriate pharmacovigilance partners.

For the drug manufacturers/MAHs who do not yet have PV systems in place, implementing these changes can seem to be an insurmountable task. However, we already have an end to end Pharmacovigilance database/software in addition to the services needed to address the new requirements. We can help companies to establish and maintain a PV system, Call Center, Screening Literature and Social Media Cases, QMS, PvMF, ICSRs, PSUR, RMP and Signal Management. In addition, we can also provide support on the PvOI and PV audits. We can help you in the transition to the new requirements and address your end to end PV needs.

If you are interested in learning more about Clinevo’s PV Software and Services, please contact us at arun.d@clinevotech.com

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By wpclinevouser