Principal Beyond M10 Bioanalytical Consulting Souderton, Pennsylvania
Over the last fifteen years, the rationale for and the approach to providing bioanalytical support to clinical studies conducted in China has significantly evolved. The objective of this presentation will be to review the changing regulated bioanalytical landscape in China. Topics to be discussed include the movement of regulated bioanalytical support from academic institutions to commercial laboratories, the placement of bioanalytical work in China to save costs, the “Healthy China” initiative, and the associated changes in the Chinese regulatory landscape, and the evolution of regulations pertaining to human genetic material, which in turn has impacted the ability to export clinical samples from China.
Learning Objectives:
Participants will understand the complexities associated with the bioanalytical support of clinical studies conducted in
China
Participants will understand how bioanalytical support for China clinical studies has evolved over the last 15 years.
Participants will understand how changing regulations have impacted the ability to export clinical samples out of China.
