Automation in Literature Monitoring Discussed by PV Inspectors at the SUKL Seminar

At the recent Seminar: News in Pharmacovigilance, pharmacovigilance inspectors from the Czech State Institute for Drug Control (SUKL) addressed the conditions and risks associated with the automation and digitalization of literature monitoring, including printed journals not available online.

Key insights from SUKL’s response:

✅ The system used must be validated.
🔄 Continuous quality control of outputs is required.
🧾 OCR-based recognition of printed journals is not fully reliable.
🔐 Even digital sources may be problematic (e.g., unreadable formats or locked documents).
📚 SUKL does not maintain or publish a recommended list of journals for case reports.

June has truly been a month of pharmacovigilance! Our team had the opportunity to attend three valuable events:

📘 SARAP 2025 Course – Updates in Drug Registration and Pharmacovigilance (Bratislava)
📙 SUKL Seminar – News in Pharmacovigilance (Prague)
📗 9th Annual Global Pharmacovigilance Summit (Prague)

It was enriching to connect with colleagues, clients, speakers, inspectors, and fellow professionals in the field of pharmacovigilance.

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