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Ensuring the high standard of quality and compliance management at all stages of biopharma products – Research & development, manufacturing and distribution
在生物医药产品的不同阶段落实一致的高标准,确保质量及合规

GSP was revised again in July 2016. Comparing with the revised version in 2015, it has clearly put forward 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 consistency evaluation for generics. All of the changes and new regulations have beamed the same signal that quality and compliance management for biopharma products 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年修改的GSP,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。

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Key Topics To Be Addressed in 2016 Include:
重点讨论话题包括:

的认证和实施落地
GMP Implementation

Implementing the high standard of quality management endorsed in GMP at all stages for biopharma products

闭环的质量监管体系
Closed-loop quality system

Linking the upstream and downstream parties to implement seamless quality and compliance management

药品可追溯系统
Drug Traceability System

Achieving end-to-end traceability system by linking different parties with the usage of best tools

生物仿制药一致性评价
Consistency Evaluation of Quality and Efficacy for Generic Drugs

Exploring the opportunities and best practices to manage the evaluation projects

演讲嘉宾包括 | Featured Speakers Includes:

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2017年的主要变化 | What’s New This Year?

It’s the first time IQPC launched Biopharma Quality and Compliance Summit in China.

 

Gathering senior leaders of quality and compliance management in charge of different stages of biopharma products including R&D, manufacturing and distribution
聚集负责产品不同阶段的质量与合规管理的高层领导,如研发、生产及运输

 

Co-locating with Biopharma Cold Chain & Temperature Management Summit to get a more comprehensive view of the quality system of biopharma industry
同期举办生物医药冷链与温控管理中国峰会,让您也更全面的视角审视生物医药行业质量体系的建立和监管

冷链峰会往届嘉宾反馈 | What Our Past Attendees of Cold Chain China Summit Had to Say

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