All times are in Central European Summer Time （GMT+2）
Workshop I: “Workshop on Nanotechnology"
Tuesday, 26 September, 2023
14:00-14:05
Welcome and introduction to the event by the Chairs
Chairs
14:05-14:15
EMA Qualification of Novel Methodologies
14:15-14:25
US FDA qualification system for NAMs
14:25-14:35
EFSA NAMs4NANO Project
14:35-14:45
EFSA NAMs Case Study on Nanocellulose: the NANOCELLUP Project
14:45-15:35
Discussion
All
15:35-16:00
Coffee/Tea break
16:00-16:05
Opening comments
Chairs
16:05-16:15
Presentation on the WHO report ‘Dietary and inhalation exposure to nano- and microplastic particles and potential implications for human health’
https://www.who.int/publications/i/item/9789240054608
16:15-16:25
Recent work on nano/microplastics from SFA
16:25-16:35
Proxy measurands for nanoplastics – Should the development of analytical methods go in this direction?
16:35-16:45
Overview of ongoing activities involving micro/ nanoplastics from US NIST
16:45-17:25
Discussion
All
17:25-17:30
Concluding remarks
Chair
Poster session & Cocktail
Workshop II: Present and future of AI, open science and transparency in regulatory science
Tuesday, 26 September, 2023
SESSION 1 | New technologies and approaches in regulatory science
14:00-14:15
Welcome and introduction to the event by the chairs
14:15-14:30
Big data/AI and their role in regulatory decision-making
14:30-14:45
Prerequisites for Data analytics and AI
14:45-15:00
The European ONTOX project: goals and first results
15:00-15:10
Q&A- identification/proposal of topics for group discussions
Chair
SESSION 2 | Breakout Group Discussions
15:10-15:50
Topic 1, 2, 3 group discussions (Heather chairs virtual)
SESSION 3 | Panel on open science, transparency and reproducibility needed in regulatory decisions
16:05-16:10
Reports back
Chairs (1 per group, 3 main points / important issues to work on)
16:10-16:40
Panel discussions
16:40-17:00
Concluding remarks
All times are in Central European Summer Time （GMT+2）
Day 1— Wednesday, 18 September, 2024: 9am-5pm
The FDA Commissioner, NCTR Director, and Arkansas Governor (TBC)
Recorded message from the Food and Drug Administration Commissioner
Session 1: Global landscape of digital technology in regulatory science (2.5hr)
Input needed: presented by individual agencies and please provide your input
09:40-10:10
Technology for future smart food
Q&A
10:40-11:10
Coffee/Tea break
11:10-11:40
Bridging the divide between scientific development and regulatory application
Q&A
11:40-12:10
The Scientific Progress of Drug Regulation in China and its Regulatory Science Development
Q&A
12:10-12:40
NIHS 150th Anniversary and Regulatory Sciences
Q&A
12:40-14:00
Networking lunch
Session2 : Digital technology to facilitate drug development and safety assessment (1.5hr)
Input needed: Potential topics to be considered and please add your topics and speaker recommendations:
•In silico-driven drug discovery and repurposing
•De-risk of drug application via computation methods
•Digital technology for improved diagnosis and therapeutic option for rare disease
•Digital regulatory science to address opioid crises, and other significantly regulatory concerns such as CBD, Nitrosamine and PFAS
14:30-14:50
Toxicokinetics Modeling
Q&A
14:50-15:10
Activities of the Japanese Center for the Validation of Alternative Methods (JaCVAM), NIHS: Development of new toxicity tests using NAM and their use in regulations
Q&A
15:10-15:30
Regulatory landscape and critical Needs for NAMs in the Hazard assessment of industrial chemicals
Q&A
15:30-15:50
Emerging technologies for protein safety
Q&A
15:50-16:10
Coffee/Tea break
Session 3: Digital technology for novel food and food safety (1.5hr)
Input needed: Potential topics to be considered and please add your topics and speaker recommendations:
•Regulatory initiatives and data science to facilitate monitoring and traceability for food safety
•Herbal medicines and dietary supplements in the digital world
•Computational methods for novel food development
•Computational methods to assess food safety
16:10-16:20
Opening Remarks
Co-Chairs
16:20-16:40
Evaluation for developmental toxicity using human iPS cells
Q&A
16:40-17:00
Quality attributes and standards for mRNA-based and Lipid-based therapeutics
Q&A
17:00-17:20
How to handle human variability in risk assessment
Q&A
17:20-17:40
Case studies on refining risk assessment of food-related substances with NAMs
Q&A
17:40-18:00
FDALabel: A tool to facilitate regulatory application of drug labeling at FDA
Q&A
18:00-18:15
Wrap-up of day 1
18:15-20:15
Poster session & Networking cocktail
Day 2— Thursday, 19 September, 2024: 9am-5pm
Session 4: Challenges and opportunities of AI/ML in regulatory science (1.5hr)
Input needed: Potential topics to be considered and please add your topics and speaker recommendations:
•Overview of regulatory efforts to guide AI/ML application
•AI/ML as New Approach Methods (NAMs)
•Successful stories in implementing AI/ML in regulatory applications
•Generative AI in regulatory science
Session 5: Expert opinions - Is regulatory science ready for AI? (1hr)
Moderator: Dr. Weida Tong, US FDA
Panelists: Dr. Thomas Hartung, Johns Hopkins University; Prof. Maurice Whelan, EC JRC
This session will present a dynamic and interactive discussion that delves into the context of applying AI in regulatory settings. The discussion will focus on several key metrics that allow for translating cutting-edge AI research into actionable insights within regulatory frameworks, including reproducibility, explainability, transparency, safety, security, hallucination, bias, etc. The panelists will not only express their expert opinions but engage in a lively exchange, either challenging or affirming each other's perspectives on these potentially controversial issues. The audience will also participate in the conversation.
Session 6: Use cases and demonstration (1hr)
Input needed: This session is to showcase the digital technologies that global regulatory agencies have been using and/or plan to apply to their regulatory space. Please provide input.
•E.g., Global Substance Registration System in FDA
•E.g., Swissmedic 4.0 to facilitate review process
•E.g., …
Session 7: Horizon scanning (1.5hr)
Input needed: Potential topics to be considered and please add your topics and speaker recommendations:
•Impact of digital technology – scientific journals’ perspective
•Digital biomarkers for regulatory science
•Role of virtual animals, digital twin, and synthetic data in regulatory science
•Standards and best practice to uptake digital technology in regulatory science
•FAIR principles to advance regulatory science in the digital world
Concluding remarks (0.5hr)
All times are in Central European Summer Time （GMT+2）
Day 2—Thursday, 28 September, 2023
SESSION 4 | Emerging Technologies
Co-Chairs: Laila Mouawad Brazilian Health Regulatory Agency (Anvisa) (BR) & Yoko Hirabayashi National Institute of Health Sciences (NIHS) (JP)
08:30-08:40
Opening Remarks
Co-Chairs
08:40-09:00
Non-Targeted Analysis
Q&A
09:00-09:20
Emerging technologies in vaccines
Q&A
09:20-09:40
Advancing Regulatory Science thru Innovation- Microphysiological Systems
Q&A
09:40-10:00
The challenge of Inter-Individual Variations for the standardisation of emerging technologies
Q&A
10:00-10:20
Safety assessment of cell-based therapeutic products derived from iPS cells
Q&A
10:20-10:40
Coffee/Tea break
SESSION 5| Artificial Intelligence /Machine Learning
Co-Chairs: Maurice Whelan, European Commission (EC, JRC) & Weida Tong, FDA (US)
10:40-10:50
Opening Remarks
Co-chairs
10:50-11:10
Newly developed artificial intelligence (AI) based bioimaging inspection system for lymph-node granuloma lesions in high-speed line slaughter plants
Q&A
11:10-11:30
Of Mice and Machines: Augmented Intelligence for Improving Chemical Safety Assessements
Q&A
11:30-11:50
GCRSR Interagency LLMs Taskforce: the Progress Report and Beyond
Q&A
11:50-12:10
AskYourDocs: harnessing the power of LLMs for a working cross-agency prototype on Information Retrieval from PDFs
Q&A
12:10-12:30
Molecular Representation for Drug Safety Assessment
Q&A
12:30-13:30
Networking lunch
SESSION 6 | Horizon scanning I
Co-Chair: Supriya Sharma Health Canada (CA) & Bo Li National Institutes for Food and Drug Control (NIFDC) (CN)
13:30-13:40
Opening Remarks
Co-Chairs
13:40-14:00
Structural analysis of therapeutic antibodies using CRYO EM
Q&A
14:00-14:20
An evidence pathway for trustworthy AI innovations: bridging the gap between developer and user communities
Q&A
14:20-14:40
TK Plate, an open access platform for TK and TD modelling
Q&A
14:40-15:00
Navigating Regulatory Genomics: Applications, Strengths, and Limitations in Monitoring Threats in the Food Supply Chain
Q&A
15:00-15:15
Short Coffee/Tea break
SESSION 7 | Horizon scanning II
Co-Chairs: Marta Hugas, former Chief Scientist, EFSA & Bill Slikker, former Director, NCTR, FDA (US)
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
15:45-16:05
Toward social implementation and regulatory acceptance of MPS
Q&A
16:05-16:25
Development status and supervision of oragnoids and organ-on-a-chip in China
Q&A
16:25-16:45
Closing remarks
