Emerging technologies for food and drug safety

被引：13

作者：

Slikker, William, Jr. ^{[1
]}

de Souza Lima, Thalita Antony ^{[2
]}

Archella, Davide ^{[3
]}

de Silva Junior, Jarbas Barbosa ^{[2
]}

Barton-Maclaren, Tara ^{[4
]}

Bo, Li ^{[5
]}

Buvinich, Danitza ^{[2
]}

Chaudhry, Qasim ^{[6
]}

Chuan, Peiying ^{[7
]}

Deluyker, Hubert ^{[3
]}

Domselaar, Gary ^{[16
]}

Freitas, Meiruze ^{[2
]}

Hardy, Barry ^{[17
]}

Eichler, Hans-Georg ^{[14
]}

Hugas, Marta ^{[3
]}

Lee, Kenneth ^{[7
]}

Liao, Chia-Ding ^{[8
]}

Loo, Lit-Hsin ^{[7
]}

Okuda, Haruhiro ^{[18
]}

Orisakwe, Orish Ebere ^{[9
]}

Patri, Anil ^{[1
]}

Sactitono, Carl ^{[1
]}

Shi, Leming ^{[10
]}

Silva, Primal ^{[11
]}

Sistare, Frank ^{[12
]}

Thakkar, Shraddha ^{[1
]}

Tong, Weida ^{[1
]}

Valdez, Mary Lou ^{[1
]}

Whelan, Maurice ^{[13
]}

Zhao-Wong, Anna ^{[15
]}

机构：

[1] US FDA, Rockville, MD 20857 USA

[2] Brazilian Hlth Surveillance Agcy ANVISA, Brasilia, DF, Brazil

[3] European Food Safety Author, Parma, Italy

[4] Hlth Canada, Existing Subst Risk Assessment Bur, Toronto, ON, Canada

[5] China Food & Drug Adm, NIFDC, Beijing, Peoples R China

[6] Univ Chester, Chester, Cheshire, England

[7] ASTAR, Singapore, Singapore

[8] Minist Hlth & Welf, Food & Drug Adm, Taipei, Taiwan

[9] Univ Port Harcourt, Port Harcourt, Nigeria

[10] Fudan Univ Shanghai, Shanghai, Peoples R China

[11] Canadian Food Inspect Agcy, Charlottetown, PE, Canada

[12] Merck & Co Inc, Safety Assessment & Lab Anim Resources, West Point, PA USA

[13] European Commiss, Joint Res Ctr, Ispra, VA, Italy

[14] European Med Agcy, London, England

[15] MedDRA Maintenance & Support Serv Org MSSO, Charlotte, NC USA

[16] Publ Hlth Agcy Canada, Edmonton, AB, Canada

[17] Douglas Connect, Basel, Switzerland

[18] Natl Inst Hlth Sci, Kawasaki, Kanagawa, Japan

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 2018年 / 98卷

关键词：

Global coalition; Emerging technologies; Food safety; Drug safety; Regulatory agencies; Alternative methods; Best practices; Cross-training; HEALTH-RISK ASSESSMENT; HEAVY-METAL HAZARDS;

D O I：

10.1016/j.yrtph.2018.07.013

中图分类号：

DF [法律]; D9 [法律]; R [医药、卫生];

学科分类号：

0301 ; 10 ;

摘要：

Emerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, the integration of emerging technologies in the regulatory decision-making process requires rigorous assessment and consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) in partnership with the Brazilian Health Surveillance Agency (ANVISA) hosted the seventh Global Summit on Regulatory Science (GSRS17) in Brasilia, Brazil on September 18-20, 2017 to discuss the role of new approaches in regulatory science with a specific emphasis on applications in food and medical product safety. The global regulatory landscape concerning the application of new technologies was assessed in several countries worldwide. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the development, application and review of emerging technologies. The need for advanced approaches to allow for faster, less expensive and more predictive methodologies was elaborated. In addition, the strengths and weaknesses of each new approach was discussed. And finally, the need for standards and reproducible approaches was reviewed to enhance the application of the emerging technologies to improve food and drug safety. The overarching goal of GSRS17 was to provide a venue where regulators and researchers meet to develop collaborations addressing the most pressing scientific challenges and facilitate the adoption of novel technical innovations to advance the field of regulatory science.

引用

页码：115 / 128

页数：14

共 17 条

[1] Technical guide for applications of gene expression profiling in human health risk assessment of environmental chemicals [J].