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EU Pharmacovigilance Regulation 2025/1466: Key Reforms for MAHs

Commission Implementing Regulation (EU) 2025/1466 brought a seismic shift in regulatory expectations on February 12, 2026. This has transformed how pharmacovigilance outsourcing is governed across the European Union. It’s not just another compliance regulation; it has...

How is literature screening evolving in 2026 with AI and automation?

Pharmacovigilance teams with manual literature screening find the process extremely exhausting and time-consuming. Regulatory bodies like EMA, FDA, and MHRA have noticed this and enforced regulatory standards for efficient and automated literature screening. With...