11th Annual Global Summit on Regulatory Science (GSRS21)
Regulatory Sciences for Food/Drug Safety with Real-World Data & Artificial Intelligence (AI)
October 4-6, 2021
7:00 – 10:00 AM (US Central Time)
Sponsored by the Global Coalition for Regulatory Science Research (GCRSR)
co-hosted by the National Center for Toxicological Research, U.S. Food and Drug Administration (FDA)
GSRS21 Highlights
Opening remarks by the FDA Acting Commissioner, Janet Woodcock.
Two keynote presentations by government-agency senior leadership from US and EU
Frank Yiannas (Deputy Commissioner for Food Policy and Response, FDA)
Stephen Quest (General Director at Joint Research Center, EU)
Platform presentations from scientists representing Brazil, Canada, EU, India, Italy, Japan, Singapore, Switzerland, and US.
A live debate on the topic, “Is Regulatory Science Ready for AI?”
A special workshop to showcase data-science tools currently in regulatory use by FDA, European Medicines Agency (EMA), and Swissmedic.
Download the GSRS21 Booklet here
Overview of GSRS21 Conference
3-Day Conference held 3 hours per day
from 7-10 a.m. U.S. Central time.
Day 1 ─ Monday, October 4: Digital Health and Safety
The program starts with opening remarks by Janet Woodcock (U.S. FDA Acting Commissioner) and the keynote address by Frank Yiannas (U.S. FDA Deputy Commissioner), followed by six international speakers and a LIVE Q & A session. The program will end with a LIVE debate on the topic, “Is Regulatory Science Ready for AI?” where two debaters take one position of either “support” or “against” the motion and their position will be reversed in the next day’s debate on the same topic.
Day 2 ─ Tuesday, October 5: Artificial Intelligence and Machine Learning
The program starts with a keynote presentation by Stephen Quest (General Director at Joint Research Center, EU), followed by six international speakers and a LIVE Q & A session. The program will end with a LIVE debate on the same topic as Day One – “Is Regulatory Science Ready for AI?” – except both debaters will argue the reversed positions compared to Day One. The main event ends with closing remarks.
Day 3 ─ Wednesday, October 6: Data Analytical Tools − for drug and food review by global regulatory agencies
The workshop will host the LIVE demonstration of data analytics tools by FDA, European Medicines Agency (EMA), and Swissmedic. These tools have been developed (or are being developed) to facilitate the regulatory application in the corresponding agencies.