Data Dose January 2024 p.2

ChatGVP - Pharmacovigilance Expert by DrugCard

Recently developed by the DrugCard team, ChatGVP is a specialized AI assistant focusing on pharmacovigilance in the context of the European Union's Good Pharmacovigilance Practices (EU GVP). Its primary function is to offer expertise on EU GVP guidelines, assisting professionals in regulatory activities such as inspections and Standard Operating Procedure (SOP) development within the pharmacovigilance domain. Chat GVP is equipped to interpret and provide insights on the EU GVP documentation, ensuring accurate and concise information. It avoids non-pharmacovigilance topics and refrains from giving medical advice. This tool aims to request clarification on vague or broad questions, ensuring the relevance and accuracy of its responses, and maintains a professional tone suitable for technical discussions in pharmacovigilance. Chat GVP is available for free in the GPT Store.

Pharmacovigilance limitations: Understanding the intricacies

Postmarketing surveillance relies on pharmacovigilance. It ensures that safety events related to drug use throughout its lifetime are collected, evaluated, and acted upon as necessary. This is done to ensure the ongoing safe use of medicines. At the point of market approval, a medicinal product’s risks and adverse effects remain undisclosed. Therefore, postmarketing safety surveillance is critical for ensuring safe and appropriate use of medicinal products. While the pharmacovigilance system has made significant strides in enhancing drug safety, it is not without its limitations. This article will delve into some of the pharmacovigilance system’s key challenges and constraints. Read more...

Why the FDA and EMA Insist You Can’t Ignore Literature Monitoring

How do pharmacovigilance specialists typically describe one of their routine tasks, literature monitoring? They often say it’s tedious but unnecessary. But is this truly the case? Would reputable regulatory bodies like the EMA, FDA, and others insist on literature monitoring in pharmacovigilance, complete with well-defined deadlines, if it weren’t an essential task?

In reality, literature monitoring is a fundamental component of pharmacovigilance. It involves systematically scanning medical journals, case reports, clinical trials, and other sources of scientific information to identify new ADRs or updates to known safety profiles. Read more...

Automation in Pharmacovigilance: A Double-Edged Sword

A significant concern for pharmaceutical companies is closely tracking publications that discuss the safety of their products. For instance, the literature search process within the EU is subject to strict regulations, necessitating weekly searches.

The rapid expansion of medical literature and the surge in scientific publications have posed growing difficulties for pharmacovigilance experts in staying updated with the most recent information. To tackle this issue, many have looked to artificial intelligence (AI) and automated systems for support. Nevertheless, there are emerging apprehensions about the reliability of AI-driven platforms. Indeed, it’s essential to delve into the root causes of these concerns among pharmacovigilance specialists and determine the extent to which these concerns are warranted. Read more...