AIRIS

Program

* KOREA TIME & DATE

Sep.10(Wed)

[Opening Ceremony]

10:00 - 10:20

Opening Remarks

Yu-Kyoung OH

MFDS Minister

Tedros Adhanom Ghebreyesus

Director General of WHO (video)

10:00 - 10:20

Congratulatory Remarks

Min-Seok KIM

Prime Minister (video)

Mojisola Christianah Adeyeye

Director General of NAFDAC

Dr. Ali Ghamrawy

Minister & Chairman of EDA

Nils Falk Bjerregaard

Director General of DKMA (video)

[Keynote Address]

10:40 - 11:10

[Keynote Address]Design of New Protein Functions Using Deep Learning

David Baker

Nobel Laureate, Professor,
The Institute for Protein Design,
The University of Washington (video)

11:10 - 11:25

Q & A (Live Q&A with on-site audience)

Session 1

Global Ecosystem for AI in Healthcare

11:30-12:20

[Panel discussion]1. Overview of regulatory approaches
2. Reflections on AIRIS 2024 Seoul Outcome Statement
3. Global Landscape Mapping on AI regulations for health

Moderator:

Kidong Park (Director, WHO)
Jong Chul Ye (Professor, KAIST)

Panelists:

Tala Fakhouri (Parexel)
Bruce Church (Aitia)
Hwayoung Lee (LG AI Research)
Pat Baird (Philips)
Simao Campos (ITU)

12:20-13:40

Lunch

Session 2

Latest Trends in AI-enabled Medical Products

13:40-16:40

[Presentation 1]Latest AI Technologies and Regulatory Trends in Pharmaceutical field

Tala Fakhouri

VP, AI & Digital Policy,
Real-World Research, Parexel International

[Presentation 2]Latest AI Technologies and Regulatory Trends in Pharmaceutical field

Minkyung Baek

Assistant Professor,
Seoul National University

[Presentation 3]The way to leverage LG EXAONE to make clinical trials effective and efficient

Hwayoung Lee

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

[Presentation 4]Gemini Digital Twins for Drug Discovery and Development

Bruce Church

Chief Mathematics Officer and EVP,
Research and Early Development
Aitia

[Presentation 5]Trends and Convergence (Including Standards)
- Lessons Learned from Other Fields

Pat Baird

Senior Regulatory Specialist,
Philips

[Presentation 6]TBD

Camille Vidal

Vice President of Regulatory Affairs, Digital, GE HealthCare

[Presentation 7]Generative AI in Medicine: Trends,
Evidence, and the SaMD Boundary

Woong Bae

CEO, Soombit.ai

Sep.11(Thu)

Session 3

AI Regulatory Frameworks

09:00-11:50

[Presentation 1]TBD

Ib Alstrup

GxP IT Medicines Inspector,
Danish Medicines Agency, Denmark

[Presentation 2]Regulatory Approaches to AI based Medical Devices in Australia

Tracey Duffy

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

[Presentation 3]Singapore’s Regulatory Landscape for AI in Medical Devices

Woei Jiuang Wong

Assistant Group Director,
Health Sciences Authority

[Presentation 4]AI Regulatory Frameworks – WHO

Sameer Pujari

Lead AI, WHO HQ Geneva

Q & A

Coffee Break

[Presentation 5]Regulatory Perspectives on AI/ML-based Medical Devices in Korea

ByungGwan Kim

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

[Presentation 6]Regulation and review points of AI-enable medical devices in Japan

Mitsuru Yuba

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

[Presentation 7]Implications of the EU AI Act for Medical Devices

Rolf (Oberlin) Hansen

Senior Advisor,
Danish Medicines Agency

[Presentation 8]The EU AI Act and interplay with EU MDR/IVDR

Nada Alkhayat

Policy Officer,
Medical Devices Unit,
European Commission

Q & A

12:00-13:00

Lunch

Session 4

AI Technologies and Regulatory Status

13:00-16:40

[Presentation 1]Rewriting Molecular Discovery: How Generative AI is Transforming Large Molecule Therapeutics

Alan Russell

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

[Presentation 2]AI’s Role in Novel Target Discovery – High Unmet Needs Areas Through Multi-Omics Interaction

Namshik Han

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

Q & A

Special Remarks

Jung-Woo HA

Senior Presidential Secretary

[Presentation 3]AI Applications in Pharmaceutical Manufacturing

Ehab Taqieddin

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

[Presentation 4]Digital Longevity Medicine

Dean Ho

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

[Presentation 5]Developing AI Knowledge and Training Tools for Regulators

Sam Halabi

Professor,
Georgetown University

Coffee Break

[Presentation 6]From Static Law to Adaptive Governance: Regulating Medical AI at the Speed of Innovation to Ensure Legal Certainty, Risk Control and Fundamental Rights Protection

Claudia Seitz

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

[Presentation 7]Cybersecurity for AI-based Digital Medical Devices

Jiho Bang

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

Q & A