AIRIS

Greeting

Co-Hosts : Ministry of Food and Drug Safety

Today, artificial intelligence (AI) is not just an innovative technology—it is transforming our daily lives more than we ever expected. This transformation is also taking place in the field of medical products. Recognizing this growing significance of AI technology, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea and the World Health Organization (WHO) will co-host the AIRIS 2025. MFDS and WHO expect the AIRIS 2025 to serve as a platform for regulators and industry to exchange insights and ideas on how to effectively utilize AI in medical product development and regulation.

Since the AIRIS 2024, there have been innovative developments in AI at an incredibly fast pace bringing fundamental changes to the development and approval of medical products. For example, we have seen the implementation of digital twins for refractory disease treatments and the advancement of Large Language Models (LLMs) for analysis of massive safety data and prediction of adverse events.

Against this backdrop, the AIRIS 2025 will continue in-depth discussions on innovation, advancement, safety and reliability of AI-enabled medical products. As the only international symposium in the field of AI-enabled medical products, the symposium will serve as a platform for practical global cooperation among regulatory authorities, businesses, and research and academic institutions.

Yu-Kyoung Oh

Minister of Food and Drug Safety

Co-Hosts : World Health Organization (WHO)

Dear Colleagues,

Artificial intelligence is rapidly reshaping our world, including the development and regulation of medical products. As AI technologies become more sophisticated and their applications in health expand, so must our collective efforts to ensure that they are safe, effective, ethical, and equitable.

It is in this spirit that the World Health Organization is pleased to co-host AIRIS 2025, alongside the Ministry of Food and Drug Safety of the Republic of Korea. Taking place from September 10 – 12, 2025 in Incheon, Republic of Korea, AIRIS 2025 brings together global regulators, researchers, industry, and innovators to share perspectives and shape coherent pathways for the regulation of AI in medical products.

AIRIS 2025 offers an important forum for regulators to convene and engage in collective dialogue on the safe and effective use of AI in medical product development. Together, we must ensure that AI technologies serve public health goals - safely, equitably, and for the benefit of all.

Building on the success of AIRIS 2024 and WHO’s guidance on Regulatory Considerations for AI in Health, this year’s symposium will explore critical developments such as the use of digital twins, large language models, and real-world implementation challenges and opportunities. By fostering global collaboration, AIRIS 2025 seeks to advance robust regulatory frameworks that protect public health while enabling responsible innovation.

We look forward to welcoming you to this important event and to working together so that safe, scientific, and equitable AI serves the health and well-being of all people, everywhere.

Sincerely,

Dr. Tedros Adhanom Ghebreyesus

Director-General
World Health Organization