Pharmacovigilance challenge with AI
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance plays a significant role in pharmaceutical and biotechnological sectors in designing of drugs and their interactions. The pharmacovigilance involves collecting information from healthcare providers and patients to know about the hazards associated with medications.
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Artificial intelligence holds great promise to address key challenges and to provide new opportunities relevant to both aspects of Pharmacovigilance. The AI Solution for Pharmacovigilance enables advanced automation by leveraging artificial intelligence and machine learning.
Using advanced analytics in the pharmacovigilance process will also aid better clustering of data and consequent discovery of associations, for instance, a selected patient group being more or less prone to developing an adverse event. In the long term, this also opens the opportunity to complement value-based reimbursement models with drug safety information.
Some activities involved in pharmacovigilance are:
Coding of adverse events
Adverse event coding is the process by which information from an AE reporter, called the "verbatim", is coded using standardized terminology from a medical coding dictionary, such as MedDRA (the most commonly used medical coding dictionary).
Expedited reporting
This refers to ICSRs (individual case safety reports) that involve a serious and unlisted event (an event not described in the drug's labeling) that is considered related to the use of the drug (US FDA). (Spontaneous reports are typically considered to have a positive causality, whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license holder.)
Clinical trial reporting
Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug. AE reporting occurs when study patients (subjects, participants) experience any kind of "untoward" event during the conducting of clinical trials.
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