All times are in Central European Summer Time (GMT+2)

 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)

 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)

Covered Topics:

•   The race for regulation: Overview of regulatory efforts to guide AI/ML application (Cesare Furlanello, HK3 Lab & LIGHT Center, Italy) (Confirmed)

•   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 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. 

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)

•   Global Substance Registration System in FDA (TBC)
•   Swissmedic 4.0 to facilitate review process (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)


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.

GSRS23 Program at Glance


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