WHY GLOBAL PHARMACOVIGILANCE NEEDS AI | CHAPTER 4Pharmacovigilance in a Globalized World
While globalization opens up countless opportunities for pharmaceutical companies and ensures that patients worldwide can access much-needed therapeutics, it also brings a unique and complex set of challenges.
The Challenges of Going Global
- Cases must be processed efficiently and accurately, and AEs identified, despite ever-larger volumes of ICSRs being submitted in many different time zones and languages, handled by local teams, and subject to different local and global regulations. If not, patient safety and human lives are at risk.
- Complex medical information must be handled securely in numerous languages and reported in a form appropriate for the target audience(s) and cognizant of diverse linguistic and cultural backgrounds. This requires both localization and centralization, which may be a new or especially challenging consideration for large companies entering new markets or with siloed local teams. There is no longer a single market to deal with but multiple, and each is unique.
- Pharmacovigilance must become more centralized in today’s global landscape. Centralization weaves local threads together to create a robust, streamlined system with fewer independent moving parts. This way of working is more efficient, enabling a more standardized quality assurance and management system with greater consistency and accuracy across all languages and locations.