Why Global Pharmacovigilance Needs AI
Life sciences organizations entering international markets require centralized workflows and swift, accurate translations — all achievable using AI innovation.
Why Global Pharmacovigilance Needs AI | Chapter 1Pharmacovigilance for Sustained Safety Evaluation
Patient safety is the highest priority when developing new medicines and drug products. While extensive clinical testing provides a strong indication of a medicine’s safety and efficacy before it is approved for market, it cannot predict all potential side effects or adverse reactions that may appear once the drug is administered to large, diverse populations over extended time periods—reactions that must be scrutinized and dealt with swiftly.
To continually monitor and ensure the safety of approved products, the pharmaceutical industry relies on rigorous, robust, and comprehensive pharmacovigilance. Pharmacovigilance is the practice of monitoring and evaluating the safety and efficacy of drugs and other medical products after they have been approved for use. It involves the collecting, processing, and evaluating of numerous individual case safety reports (ICSRs) from a product’s patient base. Often, these patient bases are becoming increasingly global as companies enter new and expanding markets worldwide.
By processing and reporting ICSRs rapidly and accurately, pharmacovigilance professionals can identify any adverse events (AEs) or reactions that occur when a medication is used in a real-world setting. This enables swift action to minimize any resulting risk to patient health and safety.