Tag: EMA

By Vigilare Biopharma June 25, 2026Pharmacovigilance

FDA, EMA, and DCGI Inspections: Common Findings and CAPA Best Practices

Regulatory inspections can feel unpredictable, but most findings follow similar tendencies across FDA, EMA, and DCGI reviews. A strong FDA inspection-readiness mindset is not about preparing for one visit; it is about building a system

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By Vigilare Biopharma June 15, 2026Pharmacovigilance

Accelerated Approval Pathways Explained FDA, EMA, Oncology and Rare Disease Programs

Accelerated approval pathways are designed to bring important therapies to patients sooner, especially in serious or life-threatening diseases with unmet medical needs. For a regulatory service provider, the key value is helping sponsors choose the

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By Vigilare Biopharma January 30, 2026Pharmacovigilance

Real-World Evidence (RWE) in Pharmacovigilance MAH Compliance and EMA’s 2026 Framework

The European Medicines Agency (EMA) is re-examining its approach to drug safety. The 2026 pharmacovigilance (PV) framework marks significant progress in using real-world evidence (RWE) to monitor medicines and inform regulatory decisions in the European

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