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How Can I Help (A)I? AI Chatbot Helps Understand the World of AI Regulation

Posted on by darion

AI chatbot RegAsk will help sponsors understand whether their design and protocols are in compliance with the appropriate guidelines. Image source: girafchik / Shutterstock

As artificial intelligence (AI) becomes more prevalent in the pharmaceutical industry, regulators have begun to develop guidelines on how it can be used. But there are challenges, especially for sponsors conducting global AI trials, in complying with regulations from different regions.

The US Food and Drug Administration (FDA) is in the process of developing guidelines for the use of artificial intelligence (AI) and machine learning (ML) in drug development and has already issued guidelines for the use of artificial intelligence (AI) and machine learning (ML) in medical devices. The European Medicines Agency (EMA) has also issued draft guidelines for the use of artificial intelligence (AI) in the drug lifecycle, covering both drugs and medical devices. In addition, sponsors must also comply with local legal frameworks, such as the European Union (EU) Artificial Intelligence (AI) Act.

Without a team that can keep up to date with all of these regulations, there is a risk that the sponsor will not be involved in the design and conduct of the clinical trial.

Singapore-based RegAsk has developed an augmented AI chatbot, RegGenius, that allows sponsors to ask questions about how they need to comply in all regions. The chatbot provides information on all regulatory guidelines.

Chief Product Technology Officer (CPTO) RegAsk Amenallah Reghimi. Image Source: RegAsk

This Clinical Trials Arena The team spoke with RegAsk Chief Product Technology Officer (CPTO), Amenallah Reghimi, about the new guidelines and how the software provides the answers sponsors need, especially with regard to interpretability.

AB: How do you see AI regulation developing?

AR: Given the speed and evolution of AI regulation, it is important for sponsors to have up-to-date, actionable information. I anticipate AI regulation will become more rigorous and comprehensive in the coming months and years, with a focus on ethical use and safety. I believe companies need to invest in a flexible and robust compliance system to ensure it can remain compliant as it changes.

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AB: There are differences between the FDA and EMA regarding the new AI guidelines that are about to be published. How does RegGenius handle this for sponsors who want to do large, global studies?

AR: This is one of the biggest challenges for RegGenius. Not only do regulations vary by country, but also by product. We work with RegGenius on four levels to help track all the latest regulatory updates across multiple agencies, ensuring that the user always has access to the latest information. RegGenius works in the background, scanning regulatory sites daily to get the most up-to-date information. Finally, it will inform the user of upcoming guidelines to be aware of so they can take them into account.

AR: RegGenius will use contextual information about a specific trial to help formulate an answer. That’s one of the most important parts of the software—the understanding that can be built in. The sponsor can input information so that the AI ​​chatbot has all the knowledge it needs about the trial to formulate an answer correctly. That includes information about geography, indication, type of drug, phase—all of that can change the regulatory considerations that the sponsor has to consider. That’s important because it reduces the likelihood of AI hallucinations.

AB: How does RegGenius manage interpretation within consulting?

AR: That’s a real challenge. Regulation is not black and white by design, and sponsors often want black and white answers. To try to address that, we have a group of regulatory experts, both internally and externally. So if there’s an interpretation, we can ask a few experts and decide on the best practice. RegGenius connects the sponsor with a network of regulatory experts and consultants who can then provide additional advice on interpretation. AI is great, it’s the people, not the technology, that are the key to success with AI. So it always comes back to that human expertise. That human expertise can bridge the gap between an open guideline and the specific needs of the sponsor. The way that this is presented to the sponsor is by providing a generated response with references and then asking if the sponsor wants to consult with an expert. That’s the best way we’ve found to navigate the intricacies of AI regulation with confidence and precision.

AB: When it comes to experts who provide further advice, what is the responsibility if the advice provided turns out to be incorrect?

AR: We have both an internal team that is client-facing and a network of experts that is not. RegGenius connects with these external partners, and the responses go through internal regulatory teams to review and verify. Because these are regulatory matters, precision and certainty are very important, so we don’t think it’s wise to connect a client directly with an external expert.