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Ensuring Closed-loop Quality Assurance for Biopharma Products at Difference Stages – Clinical, R&D, Manufacture and Distribution
在生物医药产品的研发、生产以及配送等各个阶段中确保闭环质量保证

The Chinese pharmaceutical market is increasing its dominance as a leading player in Asia. With the regulations keeping updated, it clearly shows that the market is experiencing a turbulent time and at the stage of stricter governance on product quality. How to comply with the standards of GMP and GSP and ensure a continuous high quality is maintained from the point of manufacturing to the point of dispending?

The Biopharma Week China Summit will be gathering senior leaders in APAC to navigate through the key challenges that China market is facing and explore the best practices to tackle your challenges in quality and compliance management, especially for temperature sensitive biopharma products. Jam-packed across two days with case studies from market thought-leaders, the summit presents two event agendas with the best practices and latest trends. Join your peers from biopharma manufacturing companies, CROs/CMOs, clinical/medical laboratories, distributors and other biopharma organisations with Chiefs, VPs, GMs and Heads of Operations, Quality, Compliance, Supply Chain, Logistics and Distribution.

从众多法律法规的不断出台和修改,可以很明显地看出,中国的生物医药市场正经历着一个动荡的时期,对产品质量的要求和监管趋于严格。如何将GMP、GSP中的高标准转化成产品各个阶段的实际高质量流程操作?生物医药中国周峰会将聚集亚太地区生物医药企业的高层领导,探究中国生物医药市场在质量及合规方面面临的最大挑战,特别是对温度敏感产品。

两天的主峰会中您将听到一线从业人员通过实际案例分享的最佳实践以及市场动向。不要错过这个绝佳的平台,与来自亚太不同国家的生物医药行业领袖建立联系,面对面讨论您工作中的棘手挑战,找到最佳应对方案。

Co-located Events

Biopharma cold chain has re-gained attention after the vaccine case in Shandong talking place in March 2016, in which $90 million worth of incorrectly handled vaccines were distributed all over the country, leading to 324 people being arrested so far. The incident has clearly highlighted that the quality and governance of the biopharma cold chain process in China is still below expectations. Government vows to crackdown the distribution of improper handled vaccines. How to create closed-loop supervising system to ensure the quality of cold chain storage and transportation is the prime focus for the safe consumption of temperature sensitive biopharma products.

2016年3月,数亿元未冷藏疫苗流入18省的疫苗事故震惊了整个生物医药行业,检察机关已批准逮捕324人,立案侦查相关职务犯罪100人。生物医药冷链也再次在中国市场获得极度的关注。政府下定决心加大力度治理疫苗市场,确保阻止未冷链运输产品在市场上的流通。如何建立闭环的监管体系和质量系统以确保冷链运输和储存的端到端质量控制成为了保证温度敏感的生物医药产品安全的聚焦关注点。

Key Themes

 

Establishing a closed-loop quality supervising system through strategic stakeholders’ collaboration along the cold chain
通过不同环节的有力沟通和合作建立闭环的质量监管体系

 

Ensuring temperature integrity for vaccines among different distribution parties
确保疫苗生产运输储存等各环节的温度完整监控

 

Enhancing the quality control at centres for disease control and prevention spread in different parts of China to tackle the last mile challenge
增强对疾控中心等终端的冷链质量控制,应对最后一公里的挑战

 

Transporting and storing Control-Room- Temperature/Ambient products efficiently
高效地储存和运输生物医药室温产品

Visit Website | 峰会官方网站

Download Agenda | 下载峰会议程

Review Speakers | 演讲嘉宾一览

Good Supply Practice (GSP) was revised again in July 2016. Compared with the version in 2015, it has clearly mandated the requirement of traceability system for drugs and raised the standards for vaccine distribution. In April 2016, CFDA mandated that pharmaceutical manufacturers are required to conduct the quality and efficacy evaluation for generics to ensure the consistency to the originator reference products. All the new regulations have signalled that quality and compliance management at all stages is the key focus of the market.

2016年7月,国家食品药品监督管理总局发布了关于修改《药品经营质量管理规范》(GSP)的决定。相对2015年的版本,本版GSP明确地向药品经营企业提出了建立药品追溯系统的操作性要求,并提高了疫苗配送的门槛。2016年4月,CFDA发布有关事项,落实国务院关于开展仿制药一致性评价的意见。这些变化和新政策的出台无疑都向行业发出了一个相同的信号,提高药品质量和行业集中度势在必行,而确保产品在不同阶段的质量和合规是中国生物医药市场的聚焦关注点。

Key Themes

 

Prioritising and complying with key biopharma regulations in China
在众多的生物医药法律法规中,确保运营合规

 

Effective biopharma quality management and standardisation at all stages – from research and development through to manufacturing and distribution
保证生物医药产品在各个环节的高标准质量管理

 

Developing a comprehensive traceability system now that the removal of electronic supervision code from revised GSP
在电子监管码退出GSP舞台后,为生物医药产品建立完善的可追溯系统

 

Ensuring the consistency of quality and efficacy of generics with the originator reference products
确保生物仿制药一致性评价的高质高效完成

Visit Website | 峰会官方网站

Download Agenda | 下载峰会议程

Review Speakers | 演讲嘉宾一览

演讲嘉宾包括 | Featured Speakers Includes:

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Why Should You Sponsor Bio/Pharma Week China?

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Develop and strengthen relationships with your key clients, prospects and stakeholders

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Maximize visibility of your company immersing yourself in a large gathering of your target market

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Network through face-to-face discussion and opportunities to showcase your innovative products and services

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