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AI-based regulatory compliance in drug development

Published on February 26, 2026   38 min

A selection of talks on Pharmaceutical Sciences

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0:00
This presentation is going to explain how artificial intelligence is critical for regulatory compliance in the life sciences industry, and as a key element of submissions into drug development processes. The focus of this presentation is going to be on the key success factors from data enabled by artificial intelligence, regulatory challenges that also brings opportunities to the new artificial intelligence models, but also the overall technology integration with more complex processes, such as those in regulatory affairs, compliance for the pharmaceuticals and biotechnology company. My name is Antonio Pesqueira. I'm a partner at the Dynamic Capabilities Operational Institute, and a professor at Universidade Europeia in Portugal.
0:57
For the next couple of minutes, I will walk you through a journey of eight key concepts and steps. The first one being the overview of key challenges as the key first one. The urgency and the significance of having solutions to those challenges. The third main point, the current status of the body of knowledge. So the current available publications, case studies, and the available research right now. Then the fourth point is the impact and the implications of artificial intelligence as a key solution and this will probably be the core, the main focus of this talk. Then, we are going to review the critical gaps that artificial intelligence presents to regulatory compliance. Then the connections with both concepts. So with both functions, regulatory and compliance. We will then move to the major risks, and finally, we are going to finish off with practical and real-life contributions.

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AI-based regulatory compliance in drug development

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