Adverse drug reactions (ADRs) refer to unwanted or harmful reactions experienced following the administration of a medication.
In Canada alone, the Adverse Drug Reaction Institute has estimated that there are approximately 200,000 severe ADRs each year, though it is believed that 95% of ADRs are not reported to drug manufactures or regulatory agencies such as Health Canada or the FDA. These ADRs cost the Canadian healthcare system between $13.7 and $17.7 billion each year and include the deaths of 22,000 Canadians annually.
That being said, monitoring the effects of medical drugs after they have been licensed for use is a mandatory activity for drug manufactures. This is done to identify previously unreported adverse reactions (e.g. Post-licensing) and is a process called pharmacovigilance.
Although mandatory, pharmacovigilance can be an extremely costly and complex process. Thus, identifying a streamline process to detect, assess, and prevent ADRs is a high priority for drug manufactures globally.
To make this easier, Bayer is experimenting with artificial intelligence (AI). Particularly, Bayer has partnered with professional services firm Genpact, signing a multi-year agreement for its Pharmacovigilance Artificial Intelligence (PVAI) products.
Genpact’s PVAI capabilities incorporate language processing and machine learning techniques to reliably extract and process adverse event data from unstructured and partially-structured source documents, including individual case safety reports, clinical trial data sets, and electronic health records
It’s expected that the use of PVAI will allow for safety issues to be identified more rapidly and free up resources to focus on other tasks such as risk minimization measures, all while maintaining high quality and compliance standards.
Bayer’s deal with Genpact will usher a whole new era of pharmacovigilance. Keeping up with this era will require an up-to-date understanding of software validation requirements and pharmacovigilance.
At AXSource, we offer a range of pharmacovigilance and software validation services. We also collaborate with our partner company, AXSource Infotech, which specializes in IT advisory. Together, we are here to serve as your experts in regulatory and quality compliance.
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