Jianhui Luo, M.D.

Jianhui is CMC Subject Matter Expert at Parexel. He brings CMC expertise for biologic products and expertise in CDE/NMPA’s regulatory and technical guidance on CMC for development of biological products.

Work experience

Jianhui is an ex-regulatory official of China's CDE/NMPA with expertise in the Regulatory/CMC expectations for biological products. He worked at the National Institute for the Control of Pharmaceutical and Biological Products of China (NICPBP) for 14 years. There he worked as a scientist and was responsible for vaccine development and biological products quality control. Jianhui holds expert knowledge of China Pharmacopeia on biologics and has extensive experience working with global regulatory authorities and organizations in implementing guidance for development of biologic products.

Education

Jianhui holds a MS in Medical Microbiology from the National Institute for the Control of Pharmaceutical and Biological Products, China (1990). Additionally he holds a MD in Preventive Medicine from Tongji Medical University (1985).