AI in Medicines Regulation: Two Perspectives
Artificial intelligence is rapidly changing how regulatory work is performed – both within the pharmaceutical industry and at medicines agencies. But where is AI already delivering real value, where are its limitations, and how should we manage the associated risks? Johan Strömquist, President & Chief Innovation Officer at SSI Strategy, and Gabriel Westman, Head and Scientific Lead of the AI Unit at Läkemedelsverket, will explore AI in medicines regulation from the industry and agency perspectives. Join us for two complementary presentations followed by an open discussion about where regulatory affairs may be heading next.
Artificial intelligence has moved rapidly from experimentation to practical application within pharmaceutical development and medicines regulation. Generative AI, large language models, retrieval-augmented generation, machine learning and increasingly agentic AI systems can support activities ranging from regulatory intelligence and document preparation to data analysis and assessment. At the same time, their use raises important questions concerning reliability, traceability, data protection, human oversight and regulatory responsibility.
At this event, we will examine these developments from two complementary perspectives.
Johan Strömquist, President & Chief Innovation Officer at SSI Strategy, will provide the industry perspective. Drawing on practical experience of implementing generative AI within life-science and regulatory environments, he will discuss where AI can already add value to regulatory work, how regulatory workflows may evolve, and what organisations need to consider when moving from isolated AI experiments to broader implementation.
Gabriel Westman, Head and Scientific Lead of the AI Unit at Läkemedelsverket, will provide the regulatory agency perspective. He will discuss how AI is being developed and used within medicines regulation, the opportunities and limitations regulators see in the technology, and considerations around governance, validation, security and responsible implementation.
The presentations will be followed by a moderated discussion including Q&A comparing the two perspectives.
The intention is not to present AI as either a threat or a universal solution, but to provide a practical and informed discussion of what is already happening, what is likely to come next, and what this means for professionals working with medicines regulation.
Program
Mingle from 17.30
Fireside chat starts at 18.00, event end at 20.00
Target audience
The event is intended for professionals working with pharmaceutical development and medicines regulation who want to better understand the practical impact of artificial intelligence on regulatory work. It will be particularly relevant for regulatory affairs professionals, assessors, pharmaceutical scientists, medical and clinical professionals, regulatory strategists and managers within the pharmaceutical and biotechnology sectors, authorities, academia and related organisations. No specialist knowledge of AI or data science is required.
Time & Place
Wednesday, March 10, 2027.
At 18.00 – 20.00.
This is an hybrid event that will take place on site at Apotekarsocieteten, Wallingatan 26A, and online on Zoom.
A warm welcome wishes the Section for Regulatory Affairs!