Regulation for AI, Together for Tomorrow

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

Program Book

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

Min-kyung Baek

Assistant Professor, Seoul National University

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

Senior Regulatory Specialist, Philips

Camille Vidal

Vice President of Regulatory Affairs, Digital, GE HealthCare

Woong Bae

CEO, Soombit.ai

Ib Alstrup

GxP IT Medicines Inspector, Danish Medicines Agency, Denmark

Tracey Duffy

Head, Medical Devices and Product Quality Division, Therapeutic Goods Administration, Australia

Woei Jiuang Wong

Assistant Group Director, Health Sciences Authority

Sameer Pujari

Lead AI, WHO HQ Geneva

Byung-Gwan Kim

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

Mitsuru Yuba

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

Rolf Oberlin Hansen

Senior Advisor, Danish Medicines Agency

Nada Alkhayat

Policy Officer and International Lead, European Commission

Alan Russell

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

Nam-shik Han

Professor, University of Cambridge, Yonsei University CTO & Co-founder, CardiaTec Bio Ltd

Ehab Taqieddin

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

Dean Ho

Provost’s Chair Professor, Institute Director, and Head of Department of Biomedical Engineering, National University of Singapore

Sam Halabi

Professor, Georgetown University

Claudia Seitz

Professor, Faculty of Law, Private University in the Principality of Liechtenstein (UFL)

JI-HO BANG

Managing Director, Intelligence & Information Business Division, Korea Testing Certification Institute

David Baker

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

Tala Fakhouri

Vice President, Parexel

Min-kyung Baek

Assistant Professor, Seoul National University

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

Senior Regulatory Specialist, Philips

Camille Vidal

Vice President of Regulatory Affairs, Digital, GE HealthCare

Woong Bae

CEO, Soombit.ai

Ib Alstrup

GxP IT Medicines Inspector, Danish Medicines Agency, Denmark

Tracey Duffy

Head, Medical Devices and Product Quality Division, Therapeutic Goods Administration, Australia

Woei Jiuang Wong

Assistant Group Director, Health Sciences Authority

Sameer Pujari

Lead AI, WHO HQ Geneva

Byung-Gwan Kim

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

Mitsuru Yuba

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

Rolf Oberlin Hansen

Senior Advisor, Danish Medicines Agency

Nada Alkhayat

Policy Officer and International Lead, European Commission

Alan Russell

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

Nam-shik Han

Professor, University of Cambridge, Yonsei University CTO & Co-founder, CardiaTec Bio Ltd

Ehab Taqieddin

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

Dean Ho

Provost’s Chair Professor, Institute Director, and Head of Department of Biomedical Engineering, National University of Singapore

Sam Halabi

Professor, Georgetown University

Claudia Seitz

Professor, Faculty of Law, Private University in the Principality of Liechtenstein (UFL)

JI-HO BANG

Managing Director, Intelligence & Information Business Division, Korea Testing Certification Institute