program
All times are in Central Standard Time （GMT-6）
Day 1— Wednesday, 18 September, 2024: 9am-7:30pm
Morning (9am-12pm):
Opening Remarks (0.5hr)
FDA Commissioner: Dr. Robert M. Califf (Confirmed)
NCTR Director: Dr. Tucker Patterson (Confirmed)
Arkansas Governor (TBC)
Session 1: Global landscape of digital technology in regulatory science (2.5hrs)
Covered Topics:
This session will be presented by global regulatory agencies to overview their efforts on advancing digital technology within regulatory frameworks.
Session2 : Digital technology to facilitate drug development and safety assessment (1.5hrs)
Covered Topics:
• 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
Session 3: Digital technology for novel food and food safety (1.5hrs)
Covered Topics:
• 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
Poster Session (2 hrs)
All times are in Central Standard Time （GMT-6）
Day 2— Thursday, 19 September, 2024: 9am-7:30pm
Morning (9am-12pm):
Session 4: Challenges and opportunities of AI/ML in regulatory science (1.5hrs)
Co-chair from Swissmedic (Confirmed)
Co-chair (TBD)
Covered Topics:
• AI/ML as New Approach Methods (NAMs)
• Successful stories in implementing AI/ML in regulatory applications
• Generative AI in regulatory science
• Ethical aspects of AI – stakeholder/citizen perceptions
Session 5: Expert opinions - Is regulatory science ready for AI? (1hr)
Moderator: Dr. Weida Tong, US FDA (Confirmed)
Panelists: Dr. Thomas Hartung, Johns Hopkins University (Confirmed)
Prof. Maurice Whelan, EC JRC (Confirmed)
This session is designed for debate and heated discussion of controversial issues on applying AI in regulatory science. Therefore, no more than three panelists will be included in this session. The audience will also participate in the conversation.
Afternoon (1:30pm-5pm):
Session 6: Use cases and demonstration (1hr)
Covered Topics:
This session is to showcase the digital technologies that global regulatory agencies are currently utilizing and/or plan to apply to their regulatory space.
• AI tool EPINET (ANVISA)(Confirmed)
• Introducing TKPlate - food safety without animal testing (EFSA – Dr. Jean Lou Dorne) (Confirmed)
• Swissmedic 4.0 to facilitate review process (Confirmed)
• Global Substance Registration System in FDA (TBC)
Session 7: Horizon scanning (1.5hrs)
Covered Topics:
• 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 practices to uptake digital technology in regulatory science
• FAIR principles to advance regulatory science in the digital world
Concluding remarks (0.5hr)
Evening:
Closing Reception (2 hrs) – Museum of Discovery (500 President Clinton Avenue, Little Rock)
Organizations will individually showcase a poster providing an overview of their organization during the reception.
All times are in Central Standard Time （GMT-6）
• Workshop by Swissmedic (Confirmed)
This workshop focuses on use cases of utilizing LLMs to support regulatory application organized by GCRSR Interagency LLMs Workforce.
Day 1— Wednesday, 18 September, 2024: 9am-5pm
Morning (9am-12pm):
Opening Remarks (0.5hr)
The FDA Commissioner, NCTR Director, and Arkansas Governor (TBC)
All times are in Central European Summer Time （GMT+2）
Day 2—Thursday, 28 September, 2023
08:00-08:30
Registration
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
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
11:50-12:10
AskYourDocs: harnessing the power of LLMs for a working cross-agency prototype on Information Retrieval from PDFs
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
14:40-15:00
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
GSRS23 Program at Glance
APRIL Template
Support Center
Standard Support Enquiries
standard@april.com
Premium Support Enquiries
premium@april.com