杀生物制品:风险评估,管理和沟通的机会
Byung-Mu Lee1, Angela Bearth2, Robert M Tighe3
1Division of Toxicology, College of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-Do, Republic of Korea.
概括
在COVID-19时代至关重要的杀菌产品,需要强有力的风险评估和管理,以确保公共卫生安全. 提高对它们的益处和风险的认识对于安全使用至关重要.
科学领域:
- 公共卫生 公共卫生
- 毒理学 毒理学 毒理学
- 监管科学 监管科学
背景情况:
- 在2019年冠状病毒病 (COVID-19) 流行期间,生物杀菌产品越来越多地用于控制有害生物,特别是微生物.
- 确保这些产品免受不良健康影响的安全性是由于其固有的有毒性而造成的重大公共卫生问题.
研究的目的:
- 提供对生物制药活性成分和产品的风险评估,管理和沟通策略的概述.
- 突出公众对生物制品双重性质 (有益效果和潜在毒性) 的认识的重要性.
主要方法:
- 审查美国 (FIFRA),欧盟 (BPR) 和韩国共和国 (CCPSA) 的监管框架.
- 分析风险管理方面的考虑,包括慢性疾病患者的敏感性增加.
- 检查风险传播原则,以传达潜在的危险和缓解措施.
主要成果:
- 杀生物剂产品受到国家和国际法律的不同的监管.
- 风险管理必须考虑到脆弱人群,特别是患有慢性疾病的人群,以便进行有效的营销后监测.
- 有效的风险沟通对于向公众和利益相关者提供信息至关重要.
结论:
- 参与风险评估,管理和沟通的所有利益关方的协作方法对于确保生物制品的安全至关重要.
- 安全策略的不断发展是必要的,以适应新的科学证据和公共卫生挑战.
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