Artificial Intelligence and Real-World Data for Drug and Food Safety – A Regulatory Science Perspective

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications through the annual conference Global Summit on Regulatory Science (GSRS). The 11th annual GSRS conference (GSRS21) focused on “Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI).” The conference discussed advancements in industry and academia in both AI and RWD areas with a specific emphasis on how they impact regulatory sciences and how regulatory agencies across the globe are pursuing the adaptation and oversight of these technologies. There were presentations from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the United Kingdom, and the United States. These presentations highlighted how various agencies are moving forward with these technologies by either improving the agencies’ operation and/or preparing regulatory mechanisms to approve the products containing these innovations. To increase the content and discussion, the GSRS21 hosted two debate sessions on the question of “Is Regulatory Science Ready for AI?” and a workshop to showcase the analytical data tools that global regulatory agencies have been using and/or plan to apply to regulatory science.

THAKKAR Shraddha;  SLIKKER William;  YIANNAS Frank;  SILVA Primal;  BLAIS Burton;  CHNG Kern Rei;  LIU Zhichao;  ADHOLEYA Alok;  PAPPALARDO Francesco;  CARVALHO SOARES Mônica Da Luz;  BEELER Patrick;  WHELAN Maurice;  ROBERTS Ruth;  BORLAK Jurgen;  HUGAS Martha;  TORRECILLA SALINAS Carlos;  GIRARD Philippe;  DIAMOND Matthew C.;  VERLOO Didier;  PANDA Binay;  ROSE Miquella C.;  BERENGUER JORNET Joaquim;  FURUHAMA Ayako;  FANG Hong;  KWEGYIR-AFFUL Ernest;  HEINTZ Kasey;  ARVIDSON Kirk;  GARCIA BURGOS Juan;  HORST Alexander;  TONG Weida; 

2025-05-21

ACADEMIC PRESS INC ELSEVIER SCIENCE

JRC132640

0273-2300 (online),   

https://www.sciencedirect.com/science/article/pii/S0273230023000569,    https://publications.jrc.ec.europa.eu/repository/handle/JRC132640,   

10.1016/j.yrtph.2023.105388 (online),