Ms. Jianhong Yang used to be the CMC primary reviewer for chemical drugs for respiration, Center for Drug Evaluation, CFDA; Deputy Director of Office of Review Management and Coordination; Deputy Director(acting)of Office of CMC Evaluation of Generic drugs, responsible for review and review management of generic drug applications and supplementary applications. Currently she is the researcher of Yeehong Business School of Shenyang Pharmaceutical University, engaged in drug regulatory policy research. Committee Member of the 10th and 11th Chinese Pharmacopoeia Commission.

Over the 18 years’ working experience in China National Regulatory Authority and National Control Lab and two years’ scientist/technical officer working experience in WHO HQ through international recruit process. Accumulated Chemical Manufacture and Control for biological products at both national and international level mainly covers: 1)technical review and assessment for biological products; 2)quality control assay and reference substances research and development including WHO international measurement standards; 3)technical leadership and professional input to regulatory science and regulation convergence for both CFDA and WHO written standards in the area of biologics standardization

Ms. Han received her M.S. degree in Medicinal Chemistry from Peking University Health Science Center and joined Chinese Pharmacopoeia Commission (ChPC) of CFDA in 2003 and worked 11 years there. Since May 2014, she joined the Yeehong Business School of Shenyang Pharmaceutical University as the Director of Academic Affairs, the Dean Assistant, and now Deputy Dean & Director of Academic Affairs, responsible for the Curriculum construction and academic affairs, engaged in research and teaching of drug regulatory sciences.

Carol Zhu, RPh, MBA, serves as Senior Vice President and Managing Director for DIA Greater China. She joined DIA from the Bill & Melinda Gates Foundation, where she was the Senior Program Officer for R&D Programs. Prior to her work at the Gates Foundation, she was Founder and Chief Executive Officer of START Shanghai, one of the first phase 1 oncology service companies in China. She also held positions at Merck Sharp & Dohme and GlaxoSmithKline, where she was key to establishing GSK’s R&D Center in Shanghai. Ms. Zhu earned her Masters Degree in Business Administration from Rutgers University and her undergraduate degree in pharmaceutical science from Peking University Health Science Center (Beijing Medical University).