iViReg - World Leading Technology

Your Comprehensive Hub for Pharmacovigilance Intelligence

iViReg is a groundbreaking platform that serves as a centralized repository for pharmacovigilance (PV) regulatory requirements and insights. Designed to be your single, go-to resource, iViReg offers a wealth of information that spans local, regional, and global levels.

The platform features over 400 meticulously curated Questions & Answers per country, covering the entire life cycle of a medicinal product. These Q&As are contributed by a network of local PV experts and address everything from PV systems, QPPVs, and clinical trials to post-marketing ICSR reporting, aggregate safety reports, signal management, and post-authorisation measures.

What sets iViReg apart is its commitment to accuracy and depth. Each answer is not only verified against primary evidence but also includes the "source of the truth," be it a direct hyperlink to regulatory documents, citations, or unpublished insights from local experts and competent authorities. This feature is available to Premium and Enterprise subscribers, offering an added layer of credibility and insight.

Beyond this, iViReg keeps you updated with weekly PV regulatory intelligence monitoring, ensuring you're always in the know about the latest requirements and news.

iViReg is more than just a database; it's a dynamic Knowledge Management Centre committed to delivering actionable, up-to-date, and verified pharmacovigilance intelligence.

Fully Validated for Compliance

ViReg is fully validated and complies with "21 CFR Part 11: Electronic Records; Electronic Signatures" as well as "EudraLex Volume 4; Annex 11: Computerised Systems." These certifications ensure that iViReg meets stringent regulatory standards. Additionally, our platform features audit trails to facilitate compliance during inspections.

A Multi-Faceted Approach to Data Integrity and Relevance

iViReg employs a collaborative approach by partnering with a global network of local pharmacovigilance (PV) experts who are deeply rooted in their respective regulatory landscapes. These experts contribute data that is both regulation-based and experience-based, offering a nuanced understanding of local PV systems.

Once collected, this data is subjected to a stringent multi-level verification process. Our internal PV Intelligence department cross-references the information against all available primary evidence, such as official documents and guidelines, to ensure its accuracy and reliability.

To maintain the currency of our database, we have instituted a robust monitoring process. This involves regular updates from both local PV experts and our internal PV Intelligence department, who actively monitor various sources including Competent Authorities' websites and other relevant organizations like CIOMS, UMC, WHO, and ICH.

Through this meticulous process, iViReg ensures that the data you access is not only accurate but also continually updated to reflect the latest PV regulatory changes and insights.

Structured for Comprehensive Coverage and Lifecycle Management

iViReg employs a meticulously designed data structure that categorizes information into both main and subcategories. This ensures that users can easily navigate through a wealth of pharmacovigilance (PV) information that spans the entire lifecycle of a medicinal product.

Our platform features more than 400 questions and answers, each addressed by local PV experts, offering you a nuanced understanding of regulatory landscapes across different countries. Almost every answer is accompanied by a "source of the truth," be it a source document, a citation from regulation, a direct hyperlink to the source information, or unpublished insights from local experts or competent authorities. This ensures the highest level of credibility and reliability for each piece of information.

Our categories are carefully curated to cover all critical aspects of pharmacovigilance, from the initial stages of clinical trials to post-marketing surveillance and post-authorisation measures. Within each main category, you'll find a series of subcategories that delve into even more specific areas of interest, offering a granular view of each topic.

This structured approach allows for a comprehensive understanding of PV regulatory requirements and practices. Whether you're looking into the submission of marketing authorization applications or exploring post-authorisation safety studies and signal management, iViReg provides a one-stop resource that is both exhaustive and easily navigable.

By organizing data in this manner, iViReg ensures that you have all the information you need, organized in a way that is intuitive and user-friendly, thereby facilitating effective decision-making and compliance management.

Efficient, Google-Like Search

Utilize the search bar at the top of each country profile for quick and accurate results.

Unlock In-Depth Insights and Verified Sources with Premium and Enterprise Subscriptions

iViReg goes beyond providing straightforward answers; it offers a rich, multi-layered context for each piece of information. Users with Premium and Enterprise subscriptions can unveil a wealth of additional content, including unpublished insights from local PV experts.

These unpublished insights serve as the "source of the truth" for many answers, adding an extra layer of credibility and depth. Alongside these insights, you'll often find source documents, citations from regulations, and direct hyperlinks to authoritative information. This ensures that you're not just receiving information but also understanding its foundation, thereby enhancing the credibility and reliability of the data.

Please note that this feature is available to all users with Premium and Enterprise subscriptions but is not accessible for Core users.

This feature allows you to delve deeper into the complexities of pharmacovigilance regulations and practices, offering a comprehensive view that facilitates informed decision-making.

Access to Essential Documents in Multiple Languages

iViReg not only provides comprehensive pharmacovigilance information but also includes key documents such as regulations and guidelines. These documents are available in their original languages and are continuously updated to reflect the most current information.

For broader accessibility, we are also in the process of expanding our collection of English-translated documents. While some documents are already available in English, those that are not yet translated are slated for translation and will be made available in the near future.

This dual-language approach ensures that you have the most relevant and understandable information at your fingertips, regardless of your linguistic background.

Tailored Data Retrieval for Premium and Enterprise Users

iViReg understands the diverse needs of its users when it comes to data accessibility. That's why we offer the ability to export or print crucial pharmacovigilance information. Whether you require an entire country profile, specific categories and subcategories, or even custom reports, these options are available to you.

You can choose to export the data in Excel format, which is perfect for further analysis or data manipulation. Alternatively, the print option provides a PDF-friendly format, allowing for easy sharing and offline access.

Please note that these Print and Export features are exclusive benefits for our Premium and Enterprise subscribers, adding another layer of utility and flexibility to these subscription tiers.

Advanced Comparative Analysis for Premium and Enterprise Users

iViReg offers a powerful 'My Reports' feature that allows you to conduct in-depth, cross-country comparisons of pharmacovigilance data. This feature is designed to provide you with a comprehensive view of various regulatory landscapes, enabling you to make informed decisions and strategies.

With 'My Reports,' you can create and save customized reports that focus on the specific data points most relevant to you. Whether you're interested in comparing local Qualified Person for Pharmacovigilance (QPPV) requirements, Post-Marketing ICSRs reporting requirements, or any other aspect, these reports offer a streamlined way to gather and analyze this information.

Once your report is generated, you have the option to export it to Excel, facilitating further analysis and sharing among your team.

Please note that the 'My Reports' feature is an exclusive benefit available only to our Premium and Enterprise subscribers, adding an additional layer of analytical capability to these subscription tiers.

Dynamic Monitoring and Rapid Updates for Regulatory Compliance

Yes, iViReg actively monitors PV regulatory intelligence news on a weekly basis from a variety of authoritative sources, including competent authorities' websites and other relevant organizations such as CIOMS, UMC, WHO, and ICH. This information is compiled into our iViReg Newsletter, which is released every Monday and is accessible from a dedicated 'News' page.

In addition to the newsletter, individual pieces of news are presented within each country profile, allowing for targeted information relevant to specific jurisdictions.

But we go beyond just monitoring. Each piece of news is rigorously analyzed for its potential impact on pharmacovigilance processes and the iViReg database. Our evaluation process categorizes the impact into three risk levels: low, medium, and high.

• High-Risk Updates: News categorized as high-risk triggers an immediate response, and the relevant country profiles in iViReg are updated within 48 hours.
• Medium-Risk Updates: For medium-risk news, updates are made within a two-week timeframe.
• Low-Risk Updates: Low-risk updates are incorporated within one month or by the time of the next scheduled country profile update.

This dynamic approach ensures that you always have access to the most current and relevant PV information, allowing you to maintain compliance with evolving regulations.

Dedicated Support at Your Fingertips

If you have questions or require assistance, our expert support team is readily accessible via the iViReg Chat feature. Located at the bottom right corner of the Main Dashboard, the chat is operational during our working hours from 9 a.m. to 5 p.m. Central European Time (CET). Our seasoned professionals are committed to providing timely and effective solutions, ensuring a response within 24 hours.