Regulation for AI, Together for Tomorrow
Sep.10(Wed) - 12(Fri), 2025 / INSPIRE RESORT INCHEON
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.

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)