Knowledge Management Center for Global and Local Pharmacovigilance Regulatory Intelligence
All pharmacovigilance leaders need trustworthy, current, and insightful know-how about local and global pharmacovigilance (PV) regulatory intelligence to ensure compliant and efficient practices in their organizations. Established regulatory intelligence systems, newsletters, searches, monitoring etc., used by the industry worldwide, are not specific enough, have many errors, and do not include the valuable interpretation or the actionable knowledge we need for success.
We accepted the challenge and developed a brand-new, validated, cloud-based knowledge management system focused on PV regulatory intelligence. While conducting these efforts, we recognized different unmet needs for such systems for regulatory authorities and for industry. Thus, we developed two systems – the PV-Reg system for regulators and the iViReg system for the industry!
We put the prototype of iViReg into use in June 2022, and while collecting industry feedback, we continued to fine-tune the system for over a year. The result is a fully GxP-validated iViReg version 2.0. It will provide agile PV teams with the following:
1. A robust cloud-based knowledge management system that includes, as the first global application, validated workflows for regulatory intelligence alerts.
2. The latest interpretation of regulations, including distribution rules setups for your safety database, to fully understand the PV regulatory landscape and its impact on you and your organization.
3. A customizable reporting and alert system that allows our users to receive tailored reports and notifications around the clock. Both on regulatory changes relevant to specific products and regions to support the development of effective impact analyses.
A new standard of excellence has been set: Introducing iVigee's iViReg 2.0
Designed to help companies stay compliant with near real-time local and global PV regulatory intelligence while providing a seamless and user-friendly experience.