Articles tagged with “smpc”

NLP for Prescribing Information: An Evidence-Based Review

An evidence-based review of NLP in regulatory labeling. Learn how AI assists medical writers in drafting Prescribing Information (PI/SmPC) and its limitations.

50 min read

11/23/2025

natural language processing regulatory labeling generative ai prescribing information medical writing smpc large language models regulatory affairs

SmPC Translation: How Errors Lead to Drug Recall Risks

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

45 min read

11/22/2025

pharmaceutical translation smpc drug recall labeling errors regulatory affairs patient safety ema patient information leaflet