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Best Practices for AI-Assisted Signal Detection Under GVP Module IX

Best Practices for AI-Assisted Signal Detection Under GVP Module IX

Each day, millions of patients rely on medicines that are already on the market. However, a medicine’s safety profile doesn’t cease once it reaches the market. Rare adverse events, long-term effects, and unexpected drug interactions may only emerge after widespread...

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...