ePrivacy and GPDR Cookie Consent by Cookie Consent
Choosing a Pharmacovigilance Software Vendor: A Buyer’s Checklist 

Choosing a Pharmacovigilance Software Vendor: A Buyer’s Checklist 

Choosing the right PV software vendor is a strategic decision. It affects patient safety, regulatory compliance, operational efficiency, and long‑term scalability.  Organisations can build in-house solutions, outsource PV operations, license commercial platforms, or...
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...

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...