HESI/US FDA Seminar: Risk Assessment in the 21st Century (RISK21)

At the invitation of the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), the HESI Risk Assessment in the 21st Century (RISK21) Technical Committee conducted a half-day seminar on the RISK21 approach on 18 February 2014 at FDA in College Park, Maryland. Approximately 50 FDA scientists from various centers participated in person and over 50 participants connected remotely via webinar or telephone. The seminar, organized by Dr. Sabine Francke-Carroll (US FDA/CFSAN), Dr. Suzanne Fitzpatrick (US FDA/CFSAN), and Dr. Michelle Embry (HESI), included introductory risk assessment perspectives from FDA and presentations by RISK21 leaders on the RISK21 problem formulation-based, exposure-driven, tiered data acquisition approach. A panel discussion with RISK21 and FDA representatives focused on the potential utility and applications of the RISK21 approach within FDA.

Speaker Presentations

• Full seminar video recording: http://youtu.be/oBUwD2w6SWQ
• Risk assessment at FDA:  Dr. Ronald J. Lorentzen, US FDA CFSAN
• Overview of HESI’s RISK21 Project:  Prof. Alan R. Boobis, Imperial College London, United Kingdom, RISK21 Co-Chair
• Predicting exposure potential:  Dr. Michael Dellarco, Eunice Kennedy Shriver National Institute of Child Health and Human Development, RISK21 Steering Team
• Cumulative risk:  Prof. Angelo Moretto, University of Milano, Italy, RISK21 Steering Team
• RISK21 case studies:  Dr. Timothy P. Pastoor, Syngenta Ltd., RISK21 Co-Chair

For more information about the seminar, contact Dr. Michelle Embry (membry@hesiglobal.org), Ms. Nancy Doerrer (ndoerrer@hesiglobal.org), or Dr. Jennifer Young Tanir (jtanir@hesiglobal.org).