Pharma predictions #1: AI and the local regulatory framework

Inside a pharmaceutical filling line. Image (C) Tim Sandle

In 2023 the pharmaceutical industry continued to advance with new product streams brought online and advanced technologies further embedded in operations, but what’s next? The regulatory intelligence company IQVIA has been considering what 2024 holds, albeit with a note of caution.

The focus of the industry trends and intelligence data indicates that the core areas of pharmaceutical focus are drug development, pharmacovigilance, medical information, and regulatory compliance.

To understand the drivers in relation to artificial intelligence together with the expected local regulatory challenges, Digital Journal heard from Alisa Hummings, who is the Senior Director and Head of Medical Information and Local AE Intake Services, IQVIA.

Adopting artificial intelligence

Hummings predicts that in 2024 pharmaceutical organizations will advocate for more artificial intelligence (AI) implementations. This is likely to be targeted, as she assesses: “Specifically for smaller, simple processes. These ‘low hanging fruit’ processes will be the first to be optimized. Although we will not see an overhaul of processes in the coming year, we will see tasks that require a large amount of manual effort become automated.”

Care needs to be taken when implementing this technology, however. Hummings is keen to caution: “While generative AI holds great promise, we must be sure that leveraging automated processes will be beneficial for the organization, meet the industry’s needs and ensure regulations are followed.”

Regulatory framework

A further risk emerges from pharmaceutical regulations, especially those based in individual nations. This risk is pointed out by Hummings: “As we continue to see changes in legislation and the subsequent effects on the entire industry, a major challenge will arise in the understanding and anticipation of the expectations from local inspections.”

One thing that Hummings’ finds is that local inspectors are often assessing organisational performance to a higher standard than that laid out in the legislation. This leads Hummings to forewarn: “While local legislation may provide regulatory guidance, local inspectors also provide feedback, usually much stricter than companies forecast.”

This means a focus on local regulatory trends will be important, notes Hummings: “As this pattern unfolds into the next year, organizations will look towards local contacts who fully understand the intentions of the authorities in each country they represent. Beyond that, they will realize the crucial need for documentation and technologies that support tracking and changes in legislation across borders to ensure minimal impacts to workflow, aggregate reports or risk management plans.”