Ensuring Closed-loop Quality Assurance for Biopharma Products at Difference Stages – Clinical, R&D, Manufacture and Distribution
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.
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.
Establishing a closed-loop quality supervising system through strategic stakeholders’ collaboration along the cold chain
Ensuring temperature integrity for vaccines among different distribution parties
Enhancing the quality control at centres for disease control and prevention spread in different parts of China to tackle the last mile challenge
Transporting and storing Control-Room- Temperature/Ambient products efficiently
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.
Prioritising and complying with key biopharma regulations in China
Effective biopharma quality management and standardisation at all stages – from research and development through to manufacturing and distribution
Developing a comprehensive traceability system now that the removal of electronic supervision code from revised GSP
Ensuring the consistency of quality and efficacy of generics with the originator reference products
演讲嘉宾包括 | Featured Speakers Includes:
Deputy General Manager
CR Guangdong Pharmaceuticals
Shanghai Roche Pharmaceuticals
Director of Distribution Operations Excellence
Vice President, Technology and Manufacture
Why Should You Sponsor Bio/Pharma Week China?
Develop and strengthen relationships with your key clients, prospects and stakeholders
Maximize visibility of your company immersing yourself in a large gathering of your target market
Network through face-to-face discussion and opportunities to showcase your innovative products and services
Fully engage with senior-level decision makers who are actively seeking better solutions and products to help them push digital transformation in their organizations
Branding exposure guaranteed - Leverage on our print and online advertisements, website, brochures and weekly email campaigns to reach prospective clients in the industry across Asia
Impart ideas and thought leadership when you position yourself amongst top brands and most trusted solution providers
We provide tailored business development arrangements. Simply let us know which organizations and job titles you are targeting and we will help you research, qualify and invite the specific prospects you are targeting to attend the event.