GSRS21 Program
All times are in U.S. Central Standard Time
Day 1 ─ Monday, October 4: Digital Health and Safety
7:00 – 7:30 AM
Chair: William Slikker, Jr., Director of FDA/NCTR (US)
Opening remarks: Janet Woodcock, FDA Acting Commissioner (US)
Keynote Presentation:
Real World Data and its Role in FDA’s New Era of Smarter Food Safety, Frank Yiannas, Deputy Commissioner for Food Policy and Response, FDA (US)
7:30 – 9:30 AM
Chair: Primal Silva, Canada Food Inspection Agency (CFIA) (Canada)
Food Safety Genomics, Burton Blais, CFIA (Canada)
To Unpack a Bag of Genomes: Metagenome analytics for rapid detection and genomic characterization of individual pathogens in mixed microbial communities, Kern Rei Chng, National Centre for Food Science, Singapore Food Agency (Singapore)
Exploring therapeutic options with AI for COVID-19, Zhichao Liu, FDA/NCTR (USA)
From in silico Medicine to in silico Toxicology: Applying the universal immune system simulator, Francesco Pappalardo, University of Catania (Italy)
ANVISA Open Data: The way to build evidence for health decision making, Mônica da Luz Carvalho Soares, General Manager of Knowledge, Innovation and Research, Brazilian Health Regulatory Agency – ANVISA (Brazil)
The Potential of Nationwide Administrative Hospital Data for Post-marketing Surveillance, Patrick Beeler, Swissmedic, Bern (Switzerland)
Q&A (20 Min)
Break (10 Min)
9:30 – 10:00 AM
Debate (30 Min): Is Regulatory Science Ready for AI?
Moderators:
Weida Tong, FDA/NCTR (US) and Maurice Whelan, JRC (EU)
Debaters:
Ruth Roberts, Apconix (UK) supports the motion
Jürgen Borlak, Hannover Medical School (Germany) is against the motion
All times are in U.S. Central Standard Time
Day 2 ─ Tuesday, October 5: Artificial Intelligence and Machine Learning
7:00 – 7:20 AM
Chair: Marta Hugas, Chief Scientist of EFSA (EU)
Keynote Presentation:
AI and Real-World Data for Regulatory Consideration – A Europe Perspective, Stephen Quest, General Director at JRC (EU)
7:20 – 9:20 AM
Chair: Philippe Girard, Swissmedic (Switzerland)
Tailoring FDA's Regulatory Framework to Encourage Responsible Innovation in AI/ML, Matthew Diamond, FDA/CDRH (US)
Human-Centric AI in Regulatory Science: Who is Needed Where, Didier Verloo, Head of the Assessment Methodologies Unit in EFSA (EU)
The Future of Machine Learning in Identifying Actionable Biomarkers in Cancer: An example from head and neck oncology, Binay Panda, Jawaharlal Nehru University, New Delhi (India)
Technology Innovations in Regulatory Science for Equitable Clinical Outcomes, Kelly Rose, Burroughs Wellcome Fund (US)
AI and Machine Learning in European Medicine Agencies, Joaquim Berenguer Jornet, Digital Strategy Solution in the Digital Business Transformation Task Force & Lead Data Scientist of the Analytics Centre of Excellence, EMA (EU)
Bigdata Analysis: Outcome of the 2nd AMES/QSAR International Challenge Project, Ayako Furuhama, NIHS (Japan)
Q&A (20 Min)
Break (10 Min)
9:20 – 9:50 AM
Debate (30 Min): Is Regulatory Science Ready for AI?
Moderators:
Maurice Whelan, JRC (EU) and Weida Tong, FDA/NCTR (US)
Debaters:
Jürgen Borlak, Hannover Medical School (Germany) supports the motion
Ruth Roberts, Apconix (UK) is against the motion
9:50 – 10:00 AM
Closing Remarks
Weida Tong, FDA/NCTR (US)
All times are in U.S. Central Standard Time
Day 3 ─ Wednesday, October 6: Data Analytical Tools for drug and food review by global regulatory agencies
7:00 - 10:00 AM
Chair: Shraddha Thakkar, FDA/CDER (US)
FDALabel™: A Tool to Manage Drug-Labeling Documents with Flexible Search Capabilities Used in Drug Reviews at FDA, Hong Fang, FDA/NCTR (US)
WILEE: The Warp Intelligent Learning Engine (WILEE) For Food Additive Safety, Ernest Kwegyir-Afful, FDA/CFSAN (US)
FoodTrak, Kasey Heintz, FDA/CFSAN (US)
CERES: Chemical Evaluation and Risk Estimation System, Kirk Arvidson, FDA/CFSAN (US)
ePI: electronic product information for EU medicines, Juan Garcia Burgos, EMA (EU)
LiSA - Swissmedic literature search tool, Alexander Horst, Swissmedic (Switzerland)
10:00 AM
Closing Remarks
Weida Tong, FDA/NCTR (US)