Global Summit on Regulatory Science
The Global Summit on Regulatory Science (GSRS) is an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context. The conference provides an opportunity for scientists from government, industry, and academic-research communities to objectively assess the utility of emerging technologies (such as nanotechnology, imaging, omics for translational science, personalized medicine, medical product safety, and food safety) for addressing regulatory-research questions and to discuss the best way to translate these technologies into real-world applications. The conference provides a platform where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as harmonizing strategy via global collaboration. To engage the global community to address regulatory-science research and training needs, GSRS will be held in different countries on an annual basis.
A manuscript titled “Emerging Technologies and Their Impact on Regulatory Science” that summarized the 2020 Global Summit on Regulatory Science (GSRS) was published in the journal Experimental Biology and Medicine. The publication represents many of the presentations made by scientists from NCTR and other research entities at the virtual GSRS20. There were 48 co-authors from 27 different research institutes representing 13 countries that contributed to the publication. The 13 countries include:
| Australia | Canada | China |
| Denmark | EU | France |
| Germany | Japan | Netherlands |
| Spain | Switzerland | UK |
| USA |
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 Food and Drug Administration (FDA), European Medicine Agency (EMA), and Swiss Agency for Therapeutic Products (Swissmedic).