title: Genomics in the land of regulatory science.
abstract: Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.
authors: National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA. Electronic address: Weida.tong@fda.hhs.gov.
authors: Weida
authors: W
authors: Tong
authors: Office of the Chief Scientist, US Food and Drug Administration, Silver Spring, MD, USA.
authors: Stephen
authors: S
authors: Ostroff
authors: Canadian Food Inspection Agency, Ottawa, Ontario, Canada.
authors: Burton
authors: B
authors: Blais
authors: Canadian Food Inspection Agency, Ottawa, Ontario, Canada.
authors: Primal
authors: P
authors: Silva
authors: Canadian Food Inspection Agency, Ottawa, Ontario, Canada.
authors: Martine
authors: M
authors: Dubuc
authors: Foods Standards Australia New Zealand, Canberra, ACT, Australia.
authors: Marion
authors: M
authors: Healy
authors: National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA. Electronic address: William.slikker@fda.hhs.gov.
authors: William
authors: W
authors: Slikker
mesh_terms: D019295:Computational Biology / Q000379:methods; D003657:Decision Making; D059022:Food Safety / Q000379:methods; D023281:Genomics / Q000379:methods*; D006801:Humans; D012586:Science / Q000379:methods*
keywords: Genomics; Next generation sequencing; Regulatory science