Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say will become a part of regulatory science in the coming years.
That was the main topic of discussion at the 11th Global Summit on Regulatory Science annual conference, where regulators from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the UK and the US presented the ways they are integrating AI and RWD into the operations and regulatory mechanisms of their agencies. The meeting was held virtually in October 2021 and sponsored by the Global Coalition for Regulatory Science Research (GCRSR).
The proceedings were recently summarized by Shraddha Thakkar, PhD, MSc, MS, of the Center for Drug Evaluations and Research (CDER) at the US Food and Drug Administration (FDA), and colleagues from regulatory agencies in the above countries in the journal Regulatory Toxicology and Pharmacology.
The regulators discussed in a series of debates, workshops, and presentations how AI and RWD could be applied to food and drug safety assessments, whether regulatory science was prepared for the arrival of AI, how data science tools could better align to regulatory applications, and the future of regulatory science research…
