This event was published on 7 May

Webinar: 药品对工人安全和产品安全的定量危害评估

Webinar | 18 May 2023 10:00–11:30 Beijing

本次网络研讨会将介绍 OEL 和 PDE 的概念,并讨论将风险评估方法应用于活性药物成分的非临床和临床数据,以得出科学上可靠的价值,制定用于定量监测工人暴露的遏制性能目标,并建立 分别为患者安全的可接受限度。

药物物质和药物产品的合成、配方和整体生产涉及处理许多可能引起职业和产品安全问题的化学品。需要进行定量危害评估,以建立科学合理的工作场所暴露限度,以及一种药物作为另一种药物产品中的污染物可接受的水平。 欧洲药品管理局 (EMA) 指南中定义的每日允许暴露量 (PDE) 是一种基于健康的限值,表示在以下情况下不太可能造成不良影响的剂量(口服、静脉注射或其他规定) 一个人一生中每天都会通过这条途径接触到这一剂量或低于这一剂量。 职业接触限值 (OEL) 是工人一生中每天工作 8 小时、每周工作 40 小时的可接受限值,并用作制定接触控制措施的基础。


Allan Ader 博士是位于纽约加利福尼亚州山景城的 SafeBridge Consultants, Inc. 的联合创始人兼董事总经理,该公司是为生物技术和制药行业提供高级风险评估、安全、健康和环境支持的首要资源, 纽约、英国伯里圣埃德蒙兹和弗吉尼亚州夏洛茨维尔。


This webinar will introduce the concepts of OELs and PDEs and discuss applying risk assessment methodologies to the non-clinical and clinical data on active pharmaceutical ingredients to arrive at scientifically defensible values to develop containment performance targets for the quantitative monitoring of workers’ exposure and to establish acceptable limits for patient safety, respectively.
The synthesis, formulation, and overall production of drug substances and drug products involves the handling of numerous chemicals that have the potential to create occupational and product safety concerns.
Quantitative hazard assessment is required to establish scientifically defensible limits of exposure in the workplace as well as levels of a drug substance that are acceptable as a contaminant in another drug product. A Permitted Daily Exposure (PDE), as defined in guidance by the European Medicines Agency (EMA), is a health-based limit and represents a dose (either oral, IV, or otherwise specified) that is unlikely to cause an adverse effect if an individual is exposed, by that route, at or below this dose every day for a lifetime. An Occupational Exposure Limit (OEL) is an acceptable limit for worker exposure over an 8-hour day, 40-hour week for a worker’s lifetime and is used as a basis for establishing exposure control measures.

This webinar will be held in English.

Dr. Allan Ader is co-founder and Managing Director of SafeBridge Consultants, Inc., the premier resource for high level risk assessment, safety, health and environmental support to the biotechnology and ]pharmaceutical industry, located in Mountain View, CA, New York, NY, Bury St. Edmonds, UK and Charlottesville, VA.

To register, please sign up or log into your Link account here, registration closes at 17:00, May 15(Beijing time).

18 May 2023 10:00–11:30 Beijing
This event is in the past