アメリカの薬物送達と治療学ジャーナル オープンアクセス

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Automation in Pharmacovigilance

Sunil Nighot

In today’s world of empowered patients and increased attention to drug safety, the role of Pharmacovigilance has never been more crucial. Healthcare organizations need to instill robust practices to detect, assess, report on and prevent adverse effects, both to ensure regulatory compliance and reduce risk for patients. Pharmacovigilance processes, however, are traditionally highly manual and resource-intensive. As such, adverse events are reported across the globe in multiple languages and formats and in structured, unstructured and handwritten documents from affiliates, partners and distributors. Typically, large Pharma companies receive anywhere from 300,000 to 500,000 adverse events a year. These documents are processed manually by large teams that identify and extract relevant information and enter it into the safety system. This is followed by quality and medical review before the data is reported to regulatory bodies. Automation of pharmaceutical safety case processing represents a significant opportunity to affect the strongest cost driver for a company’s overall Pharmacovigilance budget