All times are in China Standard Time （GMT+8）
Day 0 — Wednesday, 2 September 2026
13:30–16:30 PRE-CONFERENCE WORKSHOP:
ADVANCING HEALTH THROUGH INNOVATION AND EMERGING
TECHNOLOGIES IN ASIA
Regulatory Science Research on the Safety Assessment of Oligonucleotide Therapeutics
Tokuyuki Yoshida, PhD, National Institute of Health Sciences (NIHS), Japan
Preclinical Safety Evaluation and Key Concerns for Cell Therapy Products
Ying Huang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Nuclear Magnetic Resonance-Based Quantitative Technique for Reagents Used for Assays of Herbal Medicines
Michiho Ito, PhD, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences (NIHS), Japan
Innovation and Application of Key Technologies for Traditional Chinese Medicine Quality Evaluation Based on Regulatory Science
Ying Wang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Practical understanding and application of FAIR data principles.
• In silico-driven drug discovery and repurposing
• De-risk of drug applications via computational methods
• Digital technology for improved diagnosis and therapeutic options for rare disease
• Digital regulatory science to address the opioid crisis, and other significantly regulatory concerns such as CBD, Nitrosamines and PFAS
Enhance participant engagement and contribution at GSRS Conference.
Understanding FAIR data's role in research, risk assessment, and regulatory decision-making.
1. Presentations to prime detailed breakout discussion.
• Open science and FAIR data basics.
• Importance of data standards to regulators at the NIH.
• Case study on FAIRness: Drug-induced liver injury.
2. Presentations to prime detailed breakout discussion.
All times are in Central European SummerTime （GMT+2）
Day 0 — Wednesday, 2 September 2026
13:30–16:30 PRE-CONFERENCE WORKSHOP:
ADVANCING HEALTH THROUGH INNOVATION AND EMERGING
TECHNOLOGIES IN ASIA
Regulatory Science Research on the Safety Assessment of Oligonucleotide Therapeutics
Tokuyuki Yoshida, PhD, National Institute of Health Sciences (NIHS), Japan
Preclinical Safety Evaluation and Key Concerns for Cell Therapy Products
Ying Huang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Nuclear Magnetic Resonance-Based Quantitative Technique for Reagents Used for Assays of Herbal Medicines
Michiho Ito, PhD, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences (NIHS), Japan
Innovation and Application of Key Technologies for Traditional Chinese Medicine Quality Evaluation Based on Regulatory Science
Ying Wang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Pre-conference workshop on NAMs for regulatory application
Monday, September 15, 2025 | Garden Level, Room 2ABC
INSTRUCTORS:
•Gro Haarklou Mathisen, PhD. Norwegian Scientific Committee for Food and Environment
•Paul Whaley, PhD. Evidence-Based Toxicology Collaboration
•Angela Bearth, PhD. HF Partners
LEARNING OBJECTIVES:
Through a series of lectures and practical exercises, participants will develop an understanding of the concept of “internal validity” (systematic error arising from how a study is conducted), how to assess the internal validity of NAM studies in the context of systematic review (“retrospective validation”), and second-order skills relating to how to develop and select appropriate tools for assessing the internal validity of scientific studies.
AGENDA:
13:00-13:10 | Introduction to the workshop and the instructors
13:10-13:25 | Refresher on systematic review and the need for assessing bias
13:25-13:45 | How to assess internal validity, using the new INVITES-IN tool (beta version)
13:45-13:55 | How INVITES-IN was developed, with lessons for tool development in general
14:00-14:15 | Break
14:15-14:45 | Breakout session #1, familiarisation with INVITES-IN
14:45-15:05 | Q&A session, group discussion of INVITES-IN approach
15:05:15:20 | Coffee Break
15:20-16:10 | Breakout session #2, applying INVITES-IN to selected NAM studies
16:10-16:25 | Group discussion of results of assessing the selected studies
16:25-16:30 | Close
Practical understanding and application of FAIR data principles.
• In silico-driven drug discovery and repurposing
• De-risk of drug applications via computational methods
• Digital technology for improved diagnosis and therapeutic options for rare disease
• Digital regulatory science to address the opioid crisis, and other significantly regulatory concerns such as CBD, Nitrosamines and PFAS
Enhance participant engagement and contribution at GSRS Conference.
Understanding FAIR data's role in research, risk assessment, and regulatory decision-making.
1. Presentations to prime detailed breakout discussion.
• Open science and FAIR data basics.
• Importance of data standards to regulators at the NIH.
• Case study on FAIRness: Drug-induced liver injury.
2. Presentations to prime detailed breakout discussion.
All times are in China Standard Time （GMT+8）
Day 1—Thursday, 3 September 2026
8:30–9:00 OPENING REMARKS
• National Medical Products Administration (NMPA), China
• National Institutes for Food and Drug Control (NIFDC), China
• Global Coalition for Regulatory Science Research (GCRSR) Chair: Tucker Patterson, PhD, Director, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
9:00- 12:00 PLENARY SESSION:
PREPARING REGULATORY SCIENCE FOR TOMORROW
Co-Chairs: TBD
Title (TBD)
National Institutes for Food and Drug Control (NIFDC), China; National Medical Products Administration (NMPA), China
From AI Experimentation to Deploying into Production: EFSA's Recent Progress and Way Ahead
Didier Verloo, Head of Knowledge, Innovation, and Partnership Management (KNOW) Unit, European Food Safety Authority (EFSA), Italy
From AI Pilots to Production Readiness: Infrastructure and Governance Challenges for Regulatory Intelligence
Anderson da Mota Ribeiro, Coordinator of Governance, Science and Data Intelligence, Brazilian Health Regulatory Agency (ANVISA), Brazil
Regulatory Science, How the EMA Prepares for the Innovation of Tomorrow
Emmanuel Cormier, PhD, Head of the Regulatory Science and Innovation Task Force, European Medicines Agency (EMA), Netherlands
Title (TBD)
Food and Drug Administration (FDA), United States
13:30-15:20 SESSION 1: AI
Co-Chairs: (TBD)
Title (TBD)
Thomas Hartung, PhD, Chair, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health, United States; Professor, University of Konstanz, Germany
50 Shades of AI in Regulatory Science
Weida Tong, PhD, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
Virtual Clinical Trials: A Tissue-Scale Population Platform for Arrhythmia Risk and Drug Safety
Zhen Song, PhD, Peng Cheng Laboratory, China
From Regulator to Innovator: Lessons Learned Applying AI in Highly Regulated Environments
Michael Renaudin, Co-founder, Veanu, Switzerland
Generative AI for Advancing Toxicity Prediction
Dongying Li, PhD, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
Expert-driven Workflows for LLM-assisted Toxicological Risk Assessment
Arianna Bassan, PhD, Principal Consultant and Owner, Innovatune, Italy
AI as a Scientific Instrument in Biopharma
Lixian Schmid, PhD, Global regulatory affairs Scientist, CSL Behring, Switzerland
15:40-17:30 SESSION 2: PANEL DISCUSSION:
ARE NAMS READY FOR REGULATORY SCIENCE?
Moderator: (TBD)
Panel:
• Thomas Hartung, PhD, Chair, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health, United States; Professor, University of Konstanz, Germany (TBC)
• Emmanuel Cormier, PhD, Head of the Regulatory Science and Innovation Task Force, European Medicines Agency (EMA), Netherlands
• Steven Musser, PhD, Associate Commissioner, Human Foods Program, Food and Drug Administration (FDA), United States (TBC)
• Brian Berridge, DVM, PhD, DACVP, Principal Consultant, B2 Pathology Solutions LLC, Former Scientific Director, Division of Translational Toxicology, Associate Director, NTP, National Institute of Environmental Health Sciences (NIEHS), United States (TBC)
• George Kass, PhD, Professor and former Lead Expert at the European Food Safety Authority, Italy (TBC)
17:30-19:30 WELCOME RECEPTION & POSTER PRESENTATIONS
Co-Chairs: Didier Verloo, EFSA; Maurice Whelan, EC-JRC
• Are We There Yet? AI as a NAM to Replace Conventional Toxicity Testing in Pharma
Dr. Elisabeth Klenke, Chief Toxicologist, Swissmedic
• From Animals to Algorithms: AI in DILI Risk Evaluation
Dr. Weida Tong, U.S. FDA/NCTR
• In Silico NAMs for Systemic and Topical Toxicity (STopTox) Assessment
Dr. Alex Tropsha, University of North Carolina
• Exploiting AI in the Development of Adverse Outcome Pathways and Their Use in New Approaches to Safety Assessment
Clemens Wittwehr, EC/JRC
Co-Chairs:TBD
• AI-Augmented Chemical Research using Language Models
Prof. Philippe Schwaller, Laboratory of Artificial Chemical Intelligence | LIAC, EPFL
• Current Status of Understanding and Application of AI for Handling Chemical Structures
Dr. Tadahaya Mizuno, University of Tokyo
• Knowledge-Guided Toxicity Prediction – Beyond QSARs
Dr. Dongying Li, U.S. FDA/NCTR
• Language-Driven Organ Lesion Prediction in Large-Scale Toxicology
Dr. Tommaso Furlanello, HK3 Lab
4:30-4:50
Utilization of Machine Learning on the Classification of Silicone Oil Droplets and Protein Particles in Biopharmaceutical Products
Dr. Hiroko Shibata, Section Chief of Division of Biological Chemistry and Biologicals, National Institute of Health Sciences (NIHS), Japan
4:50-5:10
Top 10 AI/ML Mistakes and Villains
Dr. Russ Wolfinger, Director of Scientific Discovery and Genomics, JMP Statistical Discovery, SAS Institute Inc, USA
All times are in China Standard Time （GMT+8)
Day 2—Friday, 4 September 2026
8:30–12:00 SESSION 3: NEW APPROACH METHODOLOGIES
Co-chairs:
Didier Verloo, Head of Knowledge, Innovation, and Partnership Management
(KNOW) Unit, European Food Safety Authority (EFSA), Italy; Xiaobing Zhou,
PhD, National Institutes for Food and Drug Control (NIFDC), China
Title TBD
Zengjun Xu, PhD, Aisituokang Pharmaceutical Technology (Beijing) Co., Ltd, China
Research on Regulatory Science for Microphysiological Systems in China
Xiaobing Zhou, PhD, National Institutes for Food and Drug Control (NIFDC), China
Organ-on-Chip Approaches in Regulatory Science: Experience from BfR
Philip Marx-Stoelting, PhD, Scientific Director, Testing and Assessment Strategies Unit, German Federal Institute for Risk Assessment (BfR), Germany
Use of New Approach Methodologies in Food Safety Risk Assessment in China
Haixia Sui, PhD, China National Center for Food Safety Risk Assessment (CFSA), China
Development of a First-Pass Effect Model Using the Gut-Liver-on-Chip and Japanese Efforts Toward Proposing an Organisation for Economic Co-operation and Development Guideline
Daiju Yamazaki, PhD, Section Chief, Division of Pharmacology, National Institute of Health Sciences (NIHS), Japan
Environmental Health Applications of New Approach Methodologies: Organ-on-Chip Systems and Their Relevance in Regulatory Contexts
Tommaso Serchi, PhD, Head of Environmental Health Group - Environmental Sustainability Assessment and Circularity Research Unit, Luxembourg Institute of Science and Technology (LIST), Luxembourg
Targeting the Blood-Brain Barrier by New Approach Methodologies: A New Paradigm for Central Nervous System Safety and Efficacy
Kaoru Sato, PhD, National Institute of Health Sciences (NIHS), Japan
Standardization Supporting New Approach Methodologies: Development of ISO Standards Related to Microphysiological Systems
Hiroki Nakae, PhD, Director General, Japan Bio-Measurement and Analysis Consortium (JMAC), Japan
13:30-17:00
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 4: NANOTECHNOLOGIES
Co-Chairs:
Anil Patri, PhD, National Center for Toxicological Research, Food and Drug Administration (FDA), United States; Xingchao Geng, PhD, National Institutes for Food and Drug Control (NIFDC), China
Establishing Harmonised and Standardised Workflows for the Detection and Characterisation of Microplastics and Nanoplastics in Water and Food to Support Safety Assessment
Dingyi Yu, PhD, Singapore Food Agency (SFA), Singapore
14:20–14:40
Title (TBD)
Guangjun Nie, PhD, National Center for NanoScience and Technology (NCNST), China
14:40–15:00
Title (TBD)
Anil Patri, PhD, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
17:00-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS27
16:10–16:30
Beyond Big Data Analysis: Learn from the 2nd AMES/QSAR International Challenge Project
Dr. Ayako Furuhama, National Institute of Health Sciences (NIHS), Japan
16:30–16:50
Cutting Edge Technology in Regulatory Science – Who is doing what? A Landscape View of New Technologies Worldwide
Dr. Nicolas Löffler-Pérez, Data Scientist, Swissmedic, Switzerland
16:50–17:10
NAMs Without Borders: The 3Rs Collaborative Drives Global Awareness & Harmonization in Translational Science
Dr. Megan R. LaFollette, Executive Director, The 3Rs Collaborative, USA
17:10-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS26
All times are in Central European SummerTime （GMT+2）
Day 2-Track B—Wednesday, September 17, 2025
Nanotechnology Sessions | Garden Level, Room 1BC
9:00-10:40 NANO-SESSION 1: ADVANCED MATERIALS, SSBD IN THE
CONTEXT OF NANOMATERIALS
Co-Chairs: Dr. Birgit Sokull Kluettgen, European Commission, Joint Research Centre (JRC), Italy; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
9:00–9:20
OECD Working Party on Manufactured Nanomaterials – Important Achievements and Future Directions
Mar Gonzalez, Organization for Economic Cooperation and Development (OECD)
9:20-9:40
Safe-and-Sustainable-by-Design Drives Innovation Towards Safer and More Sustainable Nanomaterials
Drs. Hubert Rauscher & Irantzu Garmendia Aguirre, European Commission, Joint Research Centre (JRC), Italy
9:40–10:00
EFSA’s Approach to Risk Assessment of Nanomaterials and Materials Containing Small/Nanoparticles in the Food and Feed Chain
Irene Cattaneo, European Food Safety Authority (EFSA), Italy
10:00-10:20
Standardisation Efforts and Upcoming Challenges for Nanomedicines
Dr. Caterina Minelli, National Physical Laboratory, United Kingdom
10:20–10:40
Panel Discussion
11:10–12:30 NANO-SESSION 2: MEASUREMENT METHODS FOR REAL WORLD
MICRO(NANO)PLASTICS
Co-Chairs: Dr. Birgit Sokull Kluettgen, European Commission, Joint Research Centre (JRC), Italy; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
11:10–11:30
Challenges in Developing Methodologies for Legislative Monitoring of Micro(Nano)Plastics
Dr. Douglas Gilliland, European Commission, Joint Research Centre (JRC), Italy
11:30-11:50
Quantification, Characterisation, and Toxicity Assessment of Micro/Nanoplastics in Food and Drinking Water
Dr. Zhan Yuin Ong, National Centre for Food Science, Singapore Food Agency (SFA), Singapore
11:50–12:10
The POLYRISK Risk Assessment Framework for Micro- and Nanoplastic Particles (MNPs) and Its Application in Selected Case Studies
Dr. Andrea Haase, German Federal Institute for Risk Assessment (BfR), Germany
12:10-12:30
Panel Discussion
14:00- 15:20 NANO-SESSION 3: NANOMEDICINES: PROGRESS IN REGULATORY
SCIENCE
Co-Chairs: Dr. Michael Johnston, Health Canada, Canada; Dr. Birgit Sokull-Kluettgen, European Commission, Joint Research Centre (JRC), Italy
14:00–14:20
Progress and Challenges with Nanotechnology/Nanomedicines
Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
14:20-14:40
Work of the European Pharmacopeia (EDQM) on mRNA Vaccines
Prof. Gerrit Borchard, University of Geneva & EDQM, Switzerland
14:40–15:00
Quality Attributes for LNP-RNA Therapeutics: A New Generation of Medicines
Dr. Luigi Calzolai, European Commission, Joint Research Centre (JRC), Italy
15:00-15:20
Development of Prototype LNP Lyme Disease Vaccine
Dr. Michael Johnston, Health Canada, Canada
15:50–17:10 NANO-SESSION 4: NANOMEDICINES: EMERGING APPLICATIONS
Co-Chairs: Dr. Michael Johnston, Health Canada, Canada; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
15:50–16:10
Advanced Continuous Manufacturing to Accelerate Production of LNPs
Prof. Diane J. Burgess, University of Connecticut, USA
16:10-16:30
Regulatory and Research Progress on Nanomedicines in China
Dr. Xingchao Geng, National Institute for Food and Drug Control (NIFDC), China
16:30–16:50
Innovating Quality Characterization of Lipid-Based Nanomedicines: Advancing AFM and Cryo-EM Applications in Regulatory Science
Dr. Yuki Haraya, National Institute of Health Sciences (NIHS), Japan
16:50-17:10
Panel Discussion
17:10-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS26
15:15-15:25
Opening Remarks
Co-chairs
15:25-15:45
Innovation in Regulatory Science Awards at Burroughs Wellcome Fund —Preview of the Latest Technologies and Progress Towards Equitable Clinical Outcomes
Q&A
16:25-16:45
Closing remarks
