| Literature DB >> 30048704 |
William Slikker1, Thalita Antony de Souza Lima2, Davide Archella3, Jarbas Barbosa de Silva2, Tara Barton-Maclaren4, Li Bo5, Danitza Buvinich2, Qasim Chaudhry6, Peiying Chuan7, Hubert Deluyker3, Gary Domselaar8, Meiruze Freitas2, Barry Hardy9, Hans-Georg Eichler10, Marta Hugas3, Kenneth Lee7, Chia-Ding Liao11, Lit-Hsin Loo7, Haruhiro Okuda12, Orish Ebere Orisakwe13, Anil Patri14, Carl Sactitono14, Leming Shi15, Primal Silva16, Frank Sistare17, Shraddha Thakkar14, Weida Tong14, Mary Lou Valdez14, Maurice Whelan18, Anna Zhao-Wong19.
Abstract
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. Published by Elsevier Inc.Keywords: Alternative methods; Best practices; Cross-training; Drug safety; Emerging technologies; Food safety; Global coalition; Regulatory agencies
Mesh:
Year: 2018 PMID: 30048704 DOI: 10.1016/j.yrtph.2018.07.013
Source DB: PubMed Journal: Regul Toxicol Pharmacol ISSN: 0273-2300 Impact factor: 3.271