本线上研讨会由PSCI中国小组筹备，目标观众为中国供应商；会议语言为英语，欢迎国际观众注册参与。会议使用PPT为中英双语。
The webinar is sponsored by PSCI China regional team and targeting at suppliers in China.
The presentation will be delivered in English, and international audience is welcome to register & join. The presentation slides would be bilingual in Mandarin/ English.

研讨会话题
原料药和制剂生产中的活性物质操作

注册/登录PSCI账户后即可报名，报名将于5月21日下午17:00点截止。参会指引邮件将于5月22日发出。

线上研讨会话题简介
活性物质(API)的操作在药品生产过程中是一项具有挑战性的任务，一方面要避免操作人员过度职业暴露于活性物质，另一方面要避免药物交叉污染给用药患者带来不良的治疗影响。本次研讨会中，两位全球专家将基于现有GMP法规，阐述PDE和OEL值的理论设定； 从工业卫生（IH）和质量管理（GMP）领域的理论背景出发，深入探讨风险管理、遏制（containment）策略，以及相关的技术解决方案，并分享一些工程控制实例。

分享嘉宾
来自德国勃林格殷格翰总部的EHS 法规智能负责人Reinhold Maeck博士将介绍相关的原理和法规背景，来自瑞士罗氏制药全球工程咨询业务负责人Rainer Nicolai 博士将带来技术领域的深入分享。

会议语言
本次研讨会会议语言为英语。

Topic
Handling of Potent Compounds in the Manufacturing of APIs and Medicines

Please register your attendance before 21st May. We'll send out meeting instructions & link on 22nd May.

Introduction
The handling of potent compounds in the manufacturing of medicines is a challenging task. On the one hand there are operators to be protected from overexposure to materials handled, and on the other hand there are patients to be protected against false treatment due to cross contamination of medicines. In this seminar, not only both aspects will be addressed but also explained why the existing GMP regulations do help to ensure the OEL and PED values are available. Starting with the theoretical background and explaining what the expectations in the field of industrial hygiene (IH) and Good Manufacturing Practice (GMP) are, the seminar will dive into aspects of risk handling, containment strategies and technical solutions giving many examples of engineering controls to protect both - operators and patients - by technical means.

The first part on the theoretical background and the legislative situation will be covered by Dr. Reinhold Maeck, leading global EHS Regulatory Intelligence at Boehringer-Ingelheim.

The second part, diving into the technical aspects will be covered by Dr. Rainer Nicolai, Product Owner Engineering Consulting at Roche, Switzerland.

Your Presenters

• Reinhold Maeck, PhD
  Boehringer Ingelheim GmbH
  EHS Regulatory Intelligence
  Corp. EHS Regulatory Intelligence and Corporate Lead Auditor
  Chemical/ Chemical Engineering Background
  More than 30 years of International Experience in Pharmaceutical Industry
• Rainer Nicolai, PhD
  F. Hoffman - La Roche Ltd
  Product Owner Engineering Consulting
  Subject Matter Expert in Containment Technology
  Engineering Background
  More than 25 years of Experience in Contained Handling of Substances