China GMP Conference

Welcome to the:

The China GMP Conference 药品生产质量管理规范會議

本会议将以中文英文双语进行。我们将提供您同步翻译的器材。

根据国家食品药品监督管理局的公告，自去年3月1日起，所有在国内新的制药设备都必须符合新版的药品生产质量管理规范的要求。生产血液产品、疫苗、针剂和其他无菌药品的既有药厂必须在2013年12月31日前符合新规定；所有其他既有药厂必须在2015年12月 31日前符合新规定。未能在上述期限内达到新版的药品生产质量管理规范要求的制药设备将不准再从事药品生产。

本药品生产质量管理规范会议将针对药品生产业者在遵循新法规所面对的挑战进行研讨并提出解决方法。中国新版的药品生产质量管理规范与国际相关法规接近，此一同化将提升中国药品的出口潜力。我们邀请到的演讲嘉宾都是在药品生产质量管理领域中国际知名的专业人士，他们将提供他们的专业协助国内药品生产业者在新法规的遵循，加快产品上市到国际市场的时程。更重要的是，有近百位以上的药业高阶主管将参与本会议，预计将替国内委托药品生产业者带来龐大商机。

会议主题：

    新版药品生产质量管理规范的解析
    欧洲和美国药品生产质量管理规范的回顾分析
    如何使厂房符合现行的药品生产质量管理规范
    如何贯徹全公司化的质量管理系统
    如何利用良好规划的验证替公司省钱
    如何建立全公司化的审计系统
    制药设备设计如何符合药品生产质量管理规范
    优良生物药品生产质量管理规范
    质量受权人和营销授权持有人的责任
    如何进行产品的技术专移
    生产许可和药品文件的取得
    智慧产权的保护

与会人士：

    总经理、副总经理
    法规事务高级经理、总监
    生产部门高级经理
    高级审计、验证经理
    市场开发经理
    医药智慧产权专业人士
    药品生产质量管理规范顾问

立刻登记

Understanding the new SFDA GMP requirements
What will this mean for Chinese Pharmaceutical Companies?
What new opportunities does this give to export to the EU?

The State Food and Drug Administration of China (SFDA) published a revised version of the Good Manufacturing Practice for Pharmaceutical Products (GMP) regulations on the 12th February 2011. This new version came into force on the 1st March 2011. Compared to previous versions, the new GMP raises several key technical requirements in the pharmaceutical manufacturing process; it explains in great detail the responsibilities of key personnel in the manufacturing process and quality control of pharmaceuticals; it outlines more specific requirements on documentation, such as SOPs and production records; It also includes the concept of “Quality Risk Management”, and new requirements on supplier audit, change control, corrective and preventive actions, and product quality review. These requirements are very similar to the EU GMPs and are consistent with the requirements of WHO GMP.

According to the SFDA, from the 1st March 2011 all new pharmaceutical facilities in China must meet the requirements of the new GMP; existing drug manufacturers producing blood products, vaccines, injections and other sterile pharmaceutical products will be compliant with the new guidelines before the 31st December 2013; all other established facilities will be complaint before 31st December 2015. Manufacturer’s facilities that fail to meet the requirements of the new GMP won't be allowed to continue their drug production after the aforementioned deadlines.

The China GMP Conference will address the important issues elevated by the new GMP regulation and the challenges faced by Chinese pharmaceutical manufactures in compliance with the new GMP regulations. The harmonisation of Chinese GMP with international GMPs will enhance the export potential of pharmaceuticals manufactured in China. Our international business speakers are highly respected in the arena of GMP regulations. Their expertise will help you not only to implement the changes to meet regulations necessary to continue pharmaceutical production in China but also speed up your products to the global market. Most importantly, this event will attract over 100 strictly senior level representatives from Chinese pharmaceutical companies and generate international business opportunities for contractual pharmaceutical manufactures in China.

Topics that you will learn include:

Understanding the Chinese new GMP
Reviewing the regulatory landscapes in Europe and in the US
How do I get my plant to cGMP standard
How to implement a company-wide Quality Management System
How to save money with a well-planned validation
How to establish a company-wide auditing system
GMP concept design of pharmaceutical facility
Good biopharmaceutical manufacturing practice
Qualified Person and responsibilities of the Marketing Authorisation Holder
How do I tech- transfer my products
Licence and dossiers sourcing
IP protection issues

Who should attend:

CEOs, Vice Presidents and General Managers
Directors/ Senior Managers of Regulatory Affairs
Senior Managers of Manufacturing
Senior GMP Auditors and Validation Managers
Business Development Executives
Pharma IP Specialists
GMP Consultants

The official languages of the conference will be Chinese and English and you will be provided with simultaneous translation equipment.

	Welcome to the: The China GMP Conference 药品生产质量管理规范會議本会议将以中文英文双语进行。我们将提供您同步翻译的器材。根据国家食品药品监督管理局的公告，自去年3月1日起，所有在国内新的制药设备都必须符合新版的药品生产质量管理规范的要求。生产血液产品、疫苗、针剂和其他无菌药品的既有药厂必须在2013年12月31日前符合新规定；所有其他既有药厂必须在2015年12月 31日前符合新规定。未能在上述期限内达到新版的药品生产质量管理规范要求的制药设备将不准再从事药品生产。本药品生产质量管理规范会议将针对药品生产业者在遵循新法规所面对的挑战进行研讨并提出解决方法。中国新版的药品生产质量管理规范与国际相关法规接近，此一同化将提升中国药品的出口潜力。我们邀请到的演讲嘉宾都是在药品生产质量管理领域中国际知名的专业人士，他们将提供他们的专业协助国内药品生产业者在新法规的遵循，加快产品上市到国际市场的时程。更重要的是，有近百位以上的药业高阶主管将参与本会议，预计将替国内委托药品生产业者带来龐大商机。会议主题：新版药品生产质量管理规范的解析欧洲和美国药品生产质量管理规范的回顾分析如何使厂房符合现行的药品生产质量管理规范如何贯徹全公司化的质量管理系统如何利用良好规划的验证替公司省钱如何建立全公司化的审计系统制药设备设计如何符合药品生产质量管理规范优良生物药品生产质量管理规范质量受权人和营销授权持有人的责任如何进行产品的技术专移生产许可和药品文件的取得智慧产权的保护与会人士：总经理、副总经理法规事务高级经理、总监生产部门高级经理高级审计、验证经理市场开发经理医药智慧产权专业人士药品生产质量管理规范顾问立刻登记 Understanding the new SFDA GMP requirements What will this mean for Chinese Pharmaceutical Companies? What new opportunities does this give to export to the EU? The State Food and Drug Administration of China (SFDA) published a revised version of the Good Manufacturing Practice for Pharmaceutical Products (GMP) regulations on the 12th February 2011. This new version came into force on the 1st March 2011. Compared to previous versions, the new GMP raises several key technical requirements in the pharmaceutical manufacturing process; it explains in great detail the responsibilities of key personnel in the manufacturing process and quality control of pharmaceuticals; it outlines more specific requirements on documentation, such as SOPs and production records; It also includes the concept of “Quality Risk Management”, and new requirements on supplier audit, change control, corrective and preventive actions, and product quality review. These requirements are very similar to the EU GMPs and are consistent with the requirements of WHO GMP. According to the SFDA, from the 1st March 2011 all new pharmaceutical facilities in China must meet the requirements of the new GMP; existing drug manufacturers producing blood products, vaccines, injections and other sterile pharmaceutical products will be compliant with the new guidelines before the 31st December 2013; all other established facilities will be complaint before 31st December 2015. Manufacturer’s facilities that fail to meet the requirements of the new GMP won't be allowed to continue their drug production after the aforementioned deadlines. The China GMP Conference will address the important issues elevated by the new GMP regulation and the challenges faced by Chinese pharmaceutical manufactures in compliance with the new GMP regulations. The harmonisation of Chinese GMP with international GMPs will enhance the export potential of pharmaceuticals manufactured in China. Our international business speakers are highly respected in the arena of GMP regulations. Their expertise will help you not only to implement the changes to meet regulations necessary to continue pharmaceutical production in China but also speed up your products to the global market. Most importantly, this event will attract over 100 strictly senior level representatives from Chinese pharmaceutical companies and generate international business opportunities for contractual pharmaceutical manufactures in China. Topics that you will learn include: Understanding the Chinese new GMP Reviewing the regulatory landscapes in Europe and in the US How do I get my plant to cGMP standard How to implement a company-wide Quality Management System How to save money with a well-planned validation How to establish a company-wide auditing system GMP concept design of pharmaceutical facility Good biopharmaceutical manufacturing practice Qualified Person and responsibilities of the Marketing Authorisation Holder How do I tech- transfer my products Licence and dossiers sourcing IP protection issues Who should attend: CEOs, Vice Presidents and General Managers Directors/ Senior Managers of Regulatory Affairs Senior Managers of Manufacturing Senior GMP Auditors and Validation Managers Business Development Executives Pharma IP Specialists GMP Consultants The official languages of the conference will be Chinese and English and you will be provided with simultaneous translation equipment.	Click Here Conference Brochure Supported by
	For further information please contact; Steve Hambrook Conference Director steve@globalengage.co.uk +44 (0) 1865 849841 About Global Engage \| T&Cs \| Programme \| Testimonials \| Register Copyright: Global Engage Ltd Registered in England. No: 6950636