Eppendorf Webinar:Cytogenetic Gene Therapy (CGT) Product Compliance and Digitization Processes Symposium

In order to better cope with the rapid development of cytogenetic gene therapy, the relevant government departments of China have successively issued a series of guidelines and regulations to better regulate the development of the CGT product industry.Not only do regulations serve to strictly regulate the production practices followed for biopharmaceuticals, but they also play a key role in investigational new drug (IND) clinical trials and biologics license application (BLA) listing declarations.

Furthermore, as the future development of the cytogenetic gene therapy industry trends toward commercialization, upscaling, standardization and industrialization, it stands to reason that digitalization will likely be a boost. Recording and analyzing data throughout the product life cycle will guarantee product safety, controllability and traceability, which are key to ensuring the quality and compliance of CGT products in a manner consistent with the general trends of the industry’s development.

Eppendorf has been paying close attention to the development of the CGT product industry and invited special guests from the industry to come share with you what they know about the processes of cytogenetic gene therapy (CGT) product compliance and digitization. Join us on the evening of May 26th at zyt.ouryao.com to discuss the future development of cytogenetic gene therapy and the challenges that it faces.

Time:May 26, 2022 (Wednesday) at 7: 30-9:15 PM

Topics:CGT product instrument characteristics and risk assessments
Lecturer:Zhao Gaofeng, special guest of zyt.ouryao.com

> CGT product instrument characteristics
> Risk assessment
> The connection between CGT product instrument characteristics and processes

Topics:Digitization strategies for CGT products from the IND to the BLA processes
Lecturer:Fang Lei, Director of IT Compliance, ZhiMi Pharmaceutical Technology Co., Ltd., Shanghai

> Required CGT product regulations for the construction of product traceability management systems
> Digitization strategies for patient chain of identity (COI) and product chain of custody (COC)
> Personalized treatment information management platform (PTIMP)

Topics: FAQ

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