Overview
The “2nd Macau Forum on Pharmaceutical Regulatory Science & DIA Special Conference on the Greater Bay Area” co-organized by the Centre for Pharmaceutical Regulatory Sciences, University of Macau (CPRS) and the Drug Information Association (DIA) will be grandly opened in Hengqin, Guangdong and Macao on September 26-27. This conference is committed to deeply integrating international cutting-edge concepts with regional characteristic practices in the Guangdong-Hong Kong-Macao Greater Bay Area (Greater Bay Area). Focusing on the development of the pharmaceutical industry in the Greater Bay Area, this conference will deeply discuss how to optimize the policy system to promote the accelerated registration and listing of innovative drugs and devices; share international advanced clinical trial design and management experience to assist the Greater Bay Area in building an international clinical trial highland; promote global pharmaceutical innovation and development, and explore new models of deep integration of industry, academia, research and medical institutions. We look forward to meeting you in Hengqin and Macao, discussing the future pharmaceutical development in the new era, and opening a new chapter in the development of the pharmaceutical industry in the Greater Bay Area!
Featured
- The latest developments and applications of pharmaceutical regulatory policies and regulations
- Real-world evidence studies empower regulatory science
- The role of AI in clinical research design and operational quality
- Ecological construction of the pharmaceutical industry
Who should attend?
- Regulatory science professionals
- Pharmaceutical R&D, registration, and clinical research personnel
- Clinical trial institution researchers
- Academic researchers
- Clinical research organization (CRO) personnel
Venue
- September 26, 2025 (09:00-17:00) – September 27, 2025 (09:00-14:30):
Sumjoy Hengqin Tianmu Hotel, Hengqin, Guangdong
(Address: 3rd Building, Civic Service Center, No. 868, Gang’ao Avenue, Guangdong-Macao In-Depth Cooperation Zone in Hengqin) - September 27, 2025 (15:00-18:00):
Main Campus of the University of Macau, Macao
(Please note that an Exit-Entry Permit for Travelling to and from Hong Kong and Macao and the corresponding endorsement/permit for travelling to Macao are required.)
Program Committee
Program Co-chairs

Yuanjia HU, Professor
Director, Centre for Pharmaceutical Regulatory Sciences, University of Macau

Chongyuan XU, Professor
Director, GCP Center, Nanfang Hospital, Southern Medical University
Steering Committee

Xin CHEN, Professor
Director of Institute of Chinese Medical Sciences, University of Macau
Director of State Key Laboratory of Mechanism and Quality of Chinese Medicine (University of Macau)
Distinguished Professor

Wei ZHANG, MD, PhD
Senior Vice President, Head of Medicine, Greater China, Boehringer Ingelheim
Member of DIA China Advisory Committee (ACC)

Tongyan WANG, PhD
Senior Vice President and Managing Director, DIA China
Program Committee (is sorted in order of last name)

Ying BIAN, Associate Professor
Assistant Director (Medicinal Administration Education Development), Institute of Chinese Medical Sciences, University of Macau

Feng CHEN, Professor
Professor of Biostatistics, Nanjing Medical University
Chief Statistician, Greater Bay Area International Clinical Trials Center (BAY TRIAL)
Chair, Data Science Professional Committee of DIA China

Jin GAO, PhD
Secretary-General, Guangdong-Macao In-Depth Cooperation Zone in Hengqin of Healthy and Biomedical Industry Association

Hao HU, Professor
President, Macao Society for Medicinal Administration
Professor, Institute of Chinese Medical Sciences, University of Macau

Yichong LI, MD
Director of Greater Bay Area International Clinical Trials Center (BAY TRIAL)

Shanmei LIAO, PhD
Executive Director, Global Post Approval Stat and RWE, BeOne Medicines
Lead of DIA Real-World Evidence Community (RWSC)

Jessie SONG
Head of Clinical Operations, Greater China, Boehringer Ingelheim
Member, Clincial Operations Professional Committee of DIA China

Carolina, Oi Lam UNG, Assistant Professor
Deputy Director, Centre for Pharmaceutical Regulatory Sciences, University of Macau
Secretary-General, Pharmaceutical Society of Macao
Agenda
09:00-09:10 Opening & Welcome Remarks
09:10-11:00 Regulatory Science Progress in Global and the Greater Bay Area
Moderator
Yuanjia HU, Professor
Director, Centre for Pharmaceutical Regulatory Sciences, University of Macau
09:10-09:40 Keynote Speech | Global Trends and Innovation Paths in Regulatory Science
Zili LI, MD, MPH
Honorary Consultant, Department of Health, Hong Kong SAR, China
DIA and US FDA Alumni Association Board Member
09:40-10:00 Progress and Positioning of Regulatory Science in Hong Kong
Lot CHEN
Assistant Director, Medical Products Regulatory Office, Department of Health,
Hong Kong SAR, China
10:00-10:20 Implementation Status and Next Steps of the “Hong Kong and Macau Registered
Medicine Access to GBA Program”
Yun LIANG, PhD
Deputy Division Director, Administrative Licensing Division, Guangdong Provincial
Medical Products Administration
10:20-11:00 Panel Discussion | Regulatory Regional Coordination and Resource Integration
Moderator
Ling SU, PhD
DIA Fellow
Venture Partner of Lilly Asia Ventures
Researcher of Yihong Business School
Panelists
Above Speakers and Special Invited Panelists
LEI Sai Ian
Deputy Director, Pharmaceutical Administration Bureau of the Macao SAR Government
Wei ZHANG, MD, PhD
Senior Vice President, Head of Medicine, Greater China, Boehringer Ingelheim
and Panelist from the China Society for Drug Regulation
11:00-12:00 Closed-door Meeting: Challenges and Synergies in Regulatory Science Development in
the Greater Bay Area (Invited Only)
12:00-13:30 Break & Lunch
13:30-15:30 Real-world Research Empowers Regulatory Science
Session Co-Chairs
Shanmei LIAO, PhD
Executive Director, Global Post Approval Stat and RWE, BeOne Medicines
Hao HU, Professor
President, Macao Society for Medicinal Administration
Professor, Institute of Chinese Medical Sciences, University of Macau
13:30-13:45 Real-world Cases Supporting Post-marketing Safety Surveillance of Medical
Devices
Jing YUAN, Associate Professor
Associate Professor, Institute of Chinese Medical Sciences, University of Macau
13:45-14:00 Big Data and Drug Safety: Application and Frontiers of Real-World Evidence in
Regulatory Science
Francisco Tsz Tsun LAI, Assistant Professor
Assistant Professor, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty
of Medicine, The University of Hong Kong
14:00-14:15 Case Sharing on Real-world Data Supporting the R&D Life Cycle of Traditional
Chinese Medicine
Lixia(Lisa) SUN
VP & Head of Solutions Department, Tigermed
14:15-14:30 The Capabilities and Limitations of Conducting a Target Trial Based on RWD
Lihong HUANG, PhD
Director of Biostatistics Office, Zhongshan Hospital, Fudan University
14:30-15:30 Panel Discussion
Above Speakers and Invited Panelists
Feng CHEN, Professor
Professor of Biostatistics, Nanjing Medical University
Chief Statistician, Greater Bay Area International Clinical Trials Center (BAY TRIAL)
Li ZHANG, Professor
Dongfang Hospital of Beijing University of Chinese Medicine
15:30-16:00 Tea Break
16:00-17:00 Development of the Big Health Industry
Session Chair
Jin GAO, PhD
Secretary-General, Guangdong-Macao In-Depth Cooperation Zone in Hengqin of Healthy
and Biomedical Industry Association
16:00-16:15 In-depth Interpretation and Opportunity Analysis of the Big Health Industry
Policy in Guangdong-Macao In-Depth Cooperation Zone in Hengqin
Jin GAO, PhD
Secretary-General, Guangdong-Macao In-Depth Cooperation Zone in Hengqin of
Healthy and Biomedical Industry Association
16:15-16:30 Digital Intelligence Empowers the Development of Scientific Supervision
Yingjie LIU
Deputy General Manager and Chief Operating Officer, China Reform Health
Management and Services Group Co., Ltd.
16:30-16:45 To be determined
Speaker invited
16:45-17:00 Case Sharing on Supervision of Segmented Production in the Greater Bay Area
Hang CHEN
Quality Authorizer, The United Bio-pharmaceutical Co., Ltd
09:00-11:50 AI Empowers Scientific Supervision and Clinical Innovation
Session Co-Chairs
Jessie SONG
Head of Clinical Operations, Greater China, Boehringer Ingelheim
Yichong LI, MD
Director of Greater Bay Area International Clinical Trials Center (BAY TRIAL)
09:00-09:30 Trends and Responses of AI in FDA Drug Evaluation
Xin DU, PhD
Former FDA Review Specialist
CEO of Evergreen Therapeutics
09:30-10:00 Application Scenarios and Value Creation of AI Medicine
Jeannie QIU, PhD
Vice President, Global R&D Center, Fosun Pharma
10:00-10:30 Application of AI in Clinical Development: Cases, Methods and Effect Evaluation
Hao CHEN
Director, Data Intelligence, BeOne Medicines
10:30-10:50 Clinical Trial Protocol Design and Case Studies Based on AI Agent
Yinan WANG, PhD
CEO of Noah AI
10:50-11:50 Panel Discussion (Q&A)
Above Speakers
11:50-12:00 Closing Remarks
Tongyan WANG, PhD
Senior Vice President and Managing Director, DIA China
Representative from the University of Macau
13:30-14:30 Visit to the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
15:00-18:00 Exchange Activities at the University of Macau
15:00-15:30 Visit to the Institute of Chinese Medical Sciences, University of Macau / State Key
Laboratory of Mechanism and Quality of Chinese Medicine (University of Macau)
15:30-18:00 Panel Discussion: Forum on High-Quality Development of Macao and Hengqin’s
Big Health Industry in the New Era (Invited Only)
09:00-09:10 Opening & Welcome Remarks
09:10-11:00 Regulatory Science Progress in Global and the Greater
Bay Area
Moderator
Yuanjia HU, Professor
Director, Centre for Pharmaceutical Regulatory Sciences,
University of Macau
09:10-09:40 Keynote Speech | Global Trends and Innovation
Paths in Regulatory Science
Zili LI, MD, MPH
Honorary Consultant, Department of Health, Hong
Kong SAR, China
DIA and US FDA Alumni Association Board Member
09:40-10:00 Progress and Positioning of Regulatory Science in
Hong Kong
Lot CHEN
Assistant Director, Medical Products Regulatory Office,
Department of Health, Hong Kong SAR, China
10:00-10:20 Implementation Status and Next Steps of the
“Hong Kongand Macau Registered Medicine
Access to GBA Program”
Yun LIANG, PhD
Deputy Division Director, Administrative Licensing
Division, Guangdong Provincial Medical Products
Administration
10:20-11:00 Panel Discussion | Regulatory Regional
Coordination and Resource Integration
Moderator
Ling SU, PhD
DIA Fellow
Venture Partner of Lilly Asia Ventures
Researcher of Yihong Business School
Panelists
Above Speakers and Special Invited Panelists
LEI Sai Ian
Deputy Director, Pharmaceutical Administration
Bureau of the Macao SAR Government
Wei ZHANG, MD, PhD
Senior Vice President, Head of Medicine, Greater
China, Boehringer Ingelheim
and Panelist from the China Society for Drug
Regulation
11:00-12:00 Closed-door Meeting: Challenges and Synergies in
Regulatory Science Development in the Greater Bay
Area (Invited Only)
12:00-13:30 Break & Lunch
13:30-15:30 Real-world Research Empowers Regulatory Science
Session Co-Chairs
Shanmei LIAO, PhD
Executive Director, Global Post Approval Stat and RWE,
BeOne Medicines
Hao HU, Professor
President, Macao Society for Medicinal Administration
Professor, Institute of Chinese Medical Sciences, University
of Macau
13:30-13:45 Real-world Cases Supporting Post-marketing
Safety Surveillance of Medical Devices
Jing YUAN, Associate Professor
Associate Professor, Institute of Chinese Medical
Sciences, University of Macau
13:45-14:00 Big Data and Drug Safety: Application and
Frontiers of Real-World Evidence in Regulatory
Science
Francisco Tsz Tsun LAI, Assistant Professor
Assistant Professor, Department of Pharmacology and
Pharmacy, Li Ka Shing Faculty of Medicine, The
University of Hong Kong
14:00-14:15 Case Sharing on Real-world Data Supporting the
R&D Life Cycle of Traditional Chinese Medicine
Lixia(Lisa) SUN
VP & Head of Solutions Department, Tigermed
14:15-14:30 The Capabilities and Limitations of Conducting a
Target Trial Based on RWD
Lihong HUANG, PhD
Director of Biostatistics Office, Zhongshan Hospital,
Fudan University
14:30-15:30 Panel Discussion
Above Speakers and Invited Panelists
Feng CHEN, Professor
Professor of Biostatistics, Nanjing Medical University
Chief Statistician, Greater Bay Area International
Clinical Trials Center (BAY TRIAL)
Li ZHANG, Professor
Dongfang Hospital of Beijing University of Chinese
Medicine
15:30-16:00 Tea Break
16:00-17:00 Development of the Big Health Industry
Session Chair
Jin GAO, PhD
Secretary-General, Guangdong-Macao In-Depth Cooperation
Zone in Hengqin of Healthy and Biomedical Industry Association
16:00-16:15 In-depth Interpretation and Opportunity Analysis of
the Big Health Industry Policy in
Guangdong-Macao In-Depth Cooperation Zone in
Hengqin
Jin GAO, PhD
Secretary-General, Guangdong-Macao In-Depth
Cooperation Zone in Hengqin of Healthy and
Biomedical Industry Association
16:15-16:30 Digital Intelligence Empowers the Development of
Scientific Supervision
Yingjie LIU
Deputy General Manager and Chief Operating Officer,
China Reform Health Management and Services
Group Co., Ltd.
16:30-16:45 To be determined
Speaker invited
16:45-17:00 Case Sharing on Supervision of Segmented
Production in the Greater Bay Area
Hang CHEN
Quality Authorizer, The United Bio-pharmaceutical Co.,
Ltd
09:00-11:50 AI Empowers Scientific Supervision and Clinical
Innovation
Session Co-Chairs
Jessie SONG
Head of Clinical Operations, Greater China, Boehringer
Ingelheim
Yichong LI, MD
Director of Greater Bay Area International Clinical Trials
Center (BAY TRIAL)
09:00-09:30 Trends and Responses of AI in FDA Drug
Evaluation
Xin DU, PhD
Former FDA Review Specialist
CEO of Evergreen Therapeutics
09:30-10:00 Application Scenarios and Value Creation of AI
Medicine
Jeannie QIU, PhD
Vice President, Global R&D Center, Fosun Pharma
10:00-10:30 Application of AI in Clinical Development: Cases,
Methods and Effect Evaluation
Hao CHEN
Director, Data Intelligence, BeOne Medicines
10:30-10:50 Clinical Trial Protocol Design and Case Studies
Based on AI Agent
Yinan WANG, PhD
CEO of Noah AI
10:50-11:50 Panel Discussion (Q&A)
Above Speakers
11:50-12:00 Closing Remarks
Tongyan WANG, PhD
Senior Vice President and Managing Director, DIA China
Representative from the University of Macau
13:30-14:30 Visit to the Guangdong-Macao In-Depth Cooperation
Zone in Hengqin
15:00-18:00 Exchange Activities at the University of Macau
15:00-15:30 Visit to the Institute of Chinese Medical Sciences,
University of Macau / State Key Laboratory of
Mechanism and Quality of Chinese Medicine
(University of Macau)
15:30-18:00 Panel Discussion: Forum on High-Quality
Development of Macao and Hengqin’s Big Health
Industry in the New Era (Invited Only)
09:00-09:10 Opening & Welcome Remarks
09:10-11:00 Regulatory Science Progress in
Global and the Greater Bay Area
Moderator
Yuanjia HU, Professor
Director, Centre for Pharmaceutical
Regulatory Sciences, University of
Macau
09:10-09:40 Keynote Speech | Global Trends
and Innovation Paths in
Regulatory Science
Zili LI, MD, MPH
Honorary Consultant, Department
of Health, Hong Kong SAR, China
DIA and US FDA Alumni
Association Board Member
09:40-10:00 Progress and Positioning of
Regulatory Science in Hong Kong
Lot CHEN
Assistant Director, Medical
Products Regulatory Office,
Department of Health, Hong
Kong SAR, China
10:00-10:20 Implementation Status and Next
Steps of the “Hong Kong and
Macau Registered Medicine
Access to GBA Program”
Yun LIANG, PhD
Deputy Division Director,
Administrative Licensing Division,
Guangdong Provincial Medical
Products Administration
10:20-11:00 Panel Discussion | Regulatory
Regional Coordinationand
Resource Integration
Moderator
Ling SU, PhD
DIA Fellow
Venture Partner of Lilly Asia
Ventures
Researcher of Yihong Business
School
Panelists
Above Speakers and Special
Invited Panelists
LEI Sai Ian
Deputy Director, Pharmaceutical
Administration Bureau of the
Macao SAR Government
Wei ZHANG, MD, PhD
Senior Vice President, Head of
Medicine, Greater China,
Boehringer Ingelheim
and Panelist from the China
Society for Drug Regulation
11:00-12:00 Closed-door Meeting: Challenges
and Synergies in Regulatory
Science Development in the
Greater Bay Area (Invited Only)
12:00-13:30 Break & Lunch
13:30-15:30 Real-world Research Empowers
Regulatory Science
Session Co-Chairs
Shanmei LIAO, PhD
Executive Director, Global Post
Approval Stat and RWE, BeOne
Medicines
Hao HU, Professor
President, Macao Society for
Medicinal Administration
Professor, Institute of Chinese
Medical Sciences, University of
Macau
13:30-13:45 Real-world Cases Supporting
Post-marketing Safety
Surveillance of Medical Devices
Jing YUAN, Associate Professor
Associate Professor, Institute of
Chinese Medical Sciences,
University of Macau
13:45-14:00 Big Data and Drug Safety:
Application and Frontiers of
Real-World Evidence in Regulatory
Science
Francisco Tsz Tsun LAI,
Assistant Professor
Assistant Professor, Department
of Pharmacology and Pharmacy,
Li Ka Shing Faculty of Medicine,
The University of Hong Kong
14:00-14:15 Case Sharing on Real-world Data
Supporting the R&D Life Cycle of
Traditional Chinese Medicine
Lixia(Lisa) SUN
VP & Head of Solutions
Department, Tigermed
14:15-14:30 The Capabilities and Limitations
of Conducting a Target Trial
Based on RWD
Lihong HUANG, PhD
Director of Biostatistics Office,
Zhongshan Hospital, Fudan
University
14:30-15:30 Panel Discussion
Above Speakers and Invited
Panelists
Feng CHEN, Professor
Professor of Biostatistics, Nanjing
Medical University
Chief Statistician, Greater Bay Area
International Clinical Trials Center
(BAY TRIAL)
Li ZHANG, Professor
Dongfang Hospital of Beijing
University of Chinese Medicine
15:30-16:00 Tea Break
16:00-17:00 Development of the Big Health
Industry
Session Chair
Jin GAO, PhD
Secretary-General,
Guangdong-Macao In-Depth
Cooperation Zone in Hengqin of
Healthy and Biomedical Industry
Association
16:00-16:15 In-depth Interpretation and
Opportunity Analysis of the
Big Health Industry Policy
in Guangdong-Macao In-Depth
Cooperation Zone in Hengqin
Jin GAO, PhD
Secretary-General,
Guangdong-Macao In-Depth
Cooperation Zone in Hengqin of
Healthy and Biomedical Industry
Association
16:15-16:30 Digital Intelligence Empowers the
Development of Scientific
Supervision
Yingjie LIU
Deputy General Manager and Chief
Operating Officer, China Reform
Health Management and Services
Group Co., Ltd.
16:30-16:45 To be determined
Speaker invited
16:45-17:00 Case Sharing on Supervision of
Segmented Production in the
Greater Bay Area
Hang CHEN
Quality Authorizer, The United
Bio-pharmaceutical Co., Ltd
09:00-11:50 AI Empowers Scientific Supervision
and Clinical Innovation
Session Co-Chairs
Jessie SONG
Head of Clinical Operations, Greater
China, Boehringer Ingelheim
Yichong LI, MD
Director of Greater Bay Area
International Clinical Trials Center
(BAY TRIAL)
09:00-09:30 Trends and Responses of AI in
FDA Drug Evaluation
Xin DU, PhD
Former FDA Review Specialist
CEO of Evergreen Therapeutics
09:30-10:00 Application Scenarios and Value
Creation of AI Medicine
Jeannie QIU, PhD
Vice President, Global R&D Center,
Fosun Pharma
10:00-10:30 Application of AI in Clinical
Development: Cases, Methods
and Effect Evaluation
Hao CHEN
Director, Data Intelligence, BeOne
Medicines
10:30-10:50 Clinical Trial Protocol Design and
Case Studies Based on AI Agent
Yinan WANG, PhD
CEO of Noah AI
10:50-11:50 Panel Discussion (Q&A)
Above Speakers
11:50-12:00 Closing Remarks
Tongyan WANG, PhD
Senior Vice President and Managing
Director, DIA China
Representative from the University
of Macau
13:30-14:30 Visit to the Guangdong-Macao
In-Depth Cooperation Zone in
Hengqin
15:00-18:00 Exchange Activities at the University
of Macau
15:00-15:30 Visit to the Institute of Chinese
Medical Sciences, University of
Macau / State Key Laboratory of
Mechanism and Quality of Chinese
Medicine (University of Macau)
15:30-18:00 Panel Discussion: Forum on
High-Quality Development of
Macao and Hengqin’s Big Health
Industry in the New Era (Invited
Only)
Supported by:

Date and Time
September 26 (Friday), 2025
- 09:00-17:00: Conference
September 27 (Saturday), 2025
- 09:00-12:00: Conference
- 13:30-14:30: Visit to the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
- 15:00-18:00: Exchange Activities at the University of Macau
Registration
Scan the QR code above to attend the forum for free!
(Spaces are limited and available on a first come first served basis.)
Contacts
- CPRS: Stephanie Chio
Tel: +853 8822 9937
Email: stephaniechio@um.edu.mo
- DIA: Min Chu
Tel: +86.010. 5704 2659
Email: min.chu@diaglobal.org