Nick Littlebury, EVP, Regulatory Affairs at Coronado Research, discusses the latest trends in regulatory affairs and how companies can unlock the full potential of new technologies to reduce regulatory burden and help them focus on what matters most – the patient. 

The pharmaceutical industry is undergoing a period of transformation as it embraces new technologies and artificial intelligence (AI). Until now, there has been a lack of focus on specific areas like Regulatory Affairs, but that is about to change. AI and automation are reshaping the way we work, allowing us to complete tasks not just more quickly and cost effectively but more comprehensively. 

We are already seeing practical examples of how AI is being used to create pieces of evidence for the regulatory process. The use of generative AI (GenAI) to write Clinical Study Reports (CSRs) at Novo Nordisk is reportedly reducing creation time from 12 weeks to 10 minutes, with high quality outputs and lower staff resource.