Genomics in the land of regulatory science

Regulatory Toxicology and Pharmacology : RTP
Weida TongW Slikker

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 tha...Continue Reading

References

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Citations

May 22, 2016·Regulatory Toxicology and Pharmacology : RTP·Marion J HealyWilliam Slikker
Jun 8, 2017·Clinical Microbiology Reviews·Tarah LynchGary Van Domselaar
Mar 5, 2019·Journal of Clinical and Translational Science·Joan E AdamoScott J Steele
Feb 23, 2021·Regulatory Toxicology and Pharmacology : RTP·Jacqueline AllanElke Anklam

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