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  8. 11th Annual Global Summit on Regulatory Science - 10/04/2021 - 10/06/2021
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Summit | Virtual

Event Title
11th Annual Global Summit on Regulatory Science
October 4 - 6, 2021

Scheduled

Date:
October 4 - 6, 2021

GSRS21 Logo

GSRS21 – Virtual Conference

Title:         11th Annual Global Summit on Regulatory Science (GSRS21)
                  Question & Answer Sessions
Theme:     Regulatory Sciences for Food/Drug Safety with
                  Real-World Data & Artificial Intelligence (AI)

Date:         October 4-6, 2021

 

GSRS21 Summary Information

The 11th Global Summit on Regulatory Science (GSRS21) will be held virtually October 4-6, 2021, from 7-10 a.m. daily, U.S. Central time. The annual Global Summit is sponsored by the Global Coalition for Regulatory Science Research (GCRSR) which is comprised of regulatory-science leaders from around the world. NCTR’s Director serves as the co-chair of the Coalition’s executive committee and works with the Coalition to promote global interaction. This year’s virtual Global Summit will be co-hosted by NCTR. The theme for GSRS21 is “Regulatory Sciences for Food/Drug Safety with Real-World Data and Artificial Intelligence (AI).” There will be presentations and workshops, with presentations from Brazil, Canada, EU, India, Italy, Japan, Switzerland, Singapore, and the United States. Last year’s GSRS20 drew over 1,100 registrants from approximately 50 countries representing regulatory and research institutes along with academic and industry participants. The Global Summit is free to attend, but registration is required to attend the virtual conference. 
 

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.
     

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 (The FDA Acting Commissioner, US) and the keynote address by Frank Yiannas (FDA Deputy Commissioner, US), followed by six international speakers and LIVE Q & A. 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 LIVE Q & A. The program will end with a LIVE debate on the same topic as yesterday – “Is Regulatory Science Ready for AI?” – except both debaters will argue the reversed positions compared to Day 1. 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.


Registration

Registration is CLOSED.


Contact

For questions regarding meeting content please contact:

Dr. Weida Tong
GSRS21 Conference Coordinator


 
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