Tag: EU AI Act
AI pharmacovigilance: the first proving ground for the EU AI Act in pharma
Oracle Argus at 19.4% of the market, ArisGlobal LifeSphere at 17.2%. NLP that codes MedDRA with AUC 0.97. The EMA Reflection Paper of September 2024 explicitly places PV within the regulated post-authorization scope. ICH E2D(R1) enters into force in the EU on March 18, 2026. Pharmacovigilance is the first pharma use case classified as high-risk.
EU AI Act: the checklist for those who need to be ready
The EU AI Act is in force. Fines can reach up to 7% of global annual turnover. A practical guide for legal, compliance, risk and audit leaders on what to do and in what order.
AI drug discovery in 2026: between promise and production
BCG counted 73 AI-derived molecules in clinical pipelines, but success rates collapse from 80-90% in Phase I to around 40% in Phase II. Insilico Medicine's rentosertib is the first entirely AI-designed molecule to show an efficacy signal in Phase IIa, published in Nature Medicine in June 2025. An honest 2026 map: what works, what doesn't, what is changing in Europe.
