Regulation for AI, Together for Tomorrow

Sep.10(Wed) - 12(Fri), 2025 / INSPIRE RESORT INCHEON

Registration

Welcome to AIRIS 2025

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.

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Introducing the AIRIS 2025 Speakers

David Baker

Nobel laureate, professor, The Institute for Protein Design, The University of Washington

Tala Fakhouri

Vice President, Parexel (Former Associate Director, FDA CDER)

Min-kyung Baek

The Department of Biological Sciences at Seoul National University – Assistant Professor

Hwayoung Lee

Vice President, Lead of AI Business Transformation Unit, LG AI Research

Bruce Church

Chief Mathematics Officer and EVP, Research and Early Development, Aitia

Pat Baird

Philips Healthcare – Software Standards Specialist

Camille Vidal

Vice President of Regulatory Affairs for Digital Health and AI at GE HealthCare

Woong Bae

CEO of Soombit AI

Ib Alstrup

IT Medicines Inspector, Danish Medicines Agency

Tracey Duffy

Therapeutic Goods Administration (TGA) in Australia – Head of Medical Devices and Product Quality Division

Woei Jiuang Wong

Health Products Regulation Group of Health Sciences Authority (HSA) – Assistant Group Director

Sameer Pujari

AI Lead at WHO, Global Digital health Strategy & Governance, Vice Chair ITU WHO Focus Group

Matthias Neumann

Deputy Head of the Medical Devices Safety Unit at the Federal Ministry of Health, Germany

Mitsuru Yuba

Reviewer, Office of Software as a Medical Device, Pharmaceuticals and Medical Devices

Rolf Oberlin Hansen

Danish Medicines Agency’s unit for Medical Devices – Senior Advisor

Byung-Gwan Kim

Deputy Director, Medical Device Safety Bureau, Ministry of Food and Drug Safety

Nada Alkhayat

European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE) – Policy Officer

Alan Russell

Amgen, Vice President Research & Head, R&D Technology and Innovation

Nam-shik Han

Milner Therapeutics Institute, University of Cambridge – Group Leader, Head of AI Research

Ehab Taqieddin

Senior Regulatory Group Director, International Regulatory Affairs APAC. F. Hoffmann-La Roche

Abdelrahman Al Mahmoud

Director, Artificial Intelligence, Digital Economy and Remote Work Applications Office in the Prime Minister's Office, UAE

Dean Ho

Provost's Chair Professor and Head of Biomedical Engineering, National University of Singapore

Sam Halabi

Professor of Health Management and Policy at Georgetown University Medical Center

Claudia Seitz

The Faculty of Law of the University of the Principality of Liechtenstein – Professor

JI-HO BANG

Head of Intelligence & information Business Division, Korea Testing Certification Institute (KTC)

David Baker

Nobel laureate, professor, The Institute for Protein Design, The University of Washington

Tala Fakhouri

Vice President, Parexel (Former Associate Director, FDA CDER)

Min-kyung Baek

The Department of Biological Sciences at Seoul National University – Assistant Professor

Hwayoung Lee

Vice President, Lead of AI Business Transformation Unit, LG AI Research

Bruce Church

Chief Mathematics Officer and EVP, Research and Early Development, Aitia

Pat Baird

Philips Healthcare – Software Standards Specialist

Camille Vidal

Vice President of Regulatory Affairs for Digital Health and AI at GE HealthCare

Woong Bae

CEO of Soombit AI

Ib Alstrup

IT Medicines Inspector, Danish Medicines Agency

Tracey Duffy

Therapeutic Goods Administration (TGA) in Australia – Head of Medical Devices and Product Quality Division

Woei Jiuang Wong

Health Products Regulation Group of Health Sciences Authority (HSA) – Assistant Group Director

Sameer Pujari

AI Lead at WHO, Global Digital health Strategy & Governance, Vice Chair ITU WHO Focus Group

Matthias Neumann

Deputy Head of the Medical Devices Safety Unit at the Federal Ministry of Health, Germany

Mitsuru Yuba

Reviewer, Office of Software as a Medical Device, Pharmaceuticals and Medical Devices

Rolf Oberlin Hansen

Danish Medicines Agency’s unit for Medical Devices – Senior Advisor

Byung-Gwan Kim

Deputy Director, Medical Device Safety Bureau, Ministry of Food and Drug Safety

Nada Alkhayat

European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE) – Policy Officer

Alan Russell

Amgen, Vice President Research & Head, R&D Technology and Innovation

Nam-shik Han

Milner Therapeutics Institute, University of Cambridge – Group Leader, Head of AI Research

Ehab Taqieddin

Senior Regulatory Group Director, International Regulatory Affairs APAC. F. Hoffmann-La Roche

Abdelrahman Al Mahmoud

Director, Artificial Intelligence, Digital Economy and Remote Work Applications Office in the Prime Minister's Office, UAE

Dean Ho

Provost's Chair Professor and Head of Biomedical Engineering, National University of Singapore

Sam Halabi

Professor of Health Management and Policy at Georgetown University Medical Center

Claudia Seitz

The Faculty of Law of the University of the Principality of Liechtenstein – Professor

JI-HO BANG

Head of Intelligence & information Business Division, Korea Testing Certification Institute (KTC)