Pharmacovigilance

As of early 2026, France enters a new phase in clinical-research competitiveness with the roll-out of a national “fast-track” authorization pathway for certain clinical trials. Announced on 20 November 2025 by the ANSM together wi

In May 2025, the EMA (European Medicines Agency) and the HMA (Heads of Medicines Agencies) network took a significant step forward with the publication of the Workplan 2025-2028 by the Network Data Steering Group (NDSG). This plan

Pharmacovigilance compliance remains a cornerstone of drug safety, yet challenges in meeting reporting timelines and regulatory obligations persist. Non-compliance, particularly in the timely submission of suspected side effects t

I am excited to welcome 2025!2025 is here, and I am confident that this new year will bring us exceptional opportunities to innovate, collaborate, and grow together. Whether you are a pharmacist, doctor, or expert in your field, e

The European Union has just ushered in a new era with a transformative regulation on Substances of Human Origin (SoHO), effectively modernizing a framework that had been in place for two decades! This sweeping reform is set to bol