Cao Cai / Professor

Secretary General of China GCP Alliance

Secretary-General of China GCP Alliance, former Deputy Director of CFDA Drug Certification Management Center, Deputy Director of Chinese Pharmaceutical Association Drug Clinical Evaluation Research Professional Committee. Participate in and organize the drafting and revision of relevant regulations for drug registration, research, production, and circulation supervision and management, and formulate GLP and GCP on-site inspection procedures and organize the implementation of on-site inspections. Participated in the National Science and Technology 863 and undertook 6 major national special projects during the Eleventh Five-Year Plan period and 6 national science and technology support projects. Published 36 papers in national core journals of science and technology, 2 international journals, and participated in or authored 8 domestic and foreign books.

For many years, it has been mainly engaged in drug use, research and development, production, circulation, new drug review and drug supervision and management. Familiar with policies, regulations and management in the fields of drug research, production, circulation, and use. In the past ten years, he was responsible for organizing the drafting of on-site inspection procedures for drug non-clinical institutions and on-site inspection procedures for drug clinical trial institutions and organizing their implementation. Organize the drafting of on-site inspection guidance templates for drug clinical trial institutions. Participated in the drafting and formulation of "Non-clinical Drug Research Quality Management Practices" (GLP), "Pharmaceutical Clinical Trial Quality Management Practices" (GCP) specifications, implementation methods, and inspection standards, and was responsible for organizing GCL and GCP on-site inspections and inspection audits. In addition, he has participated in the drafting and revision of the "Administrative Measures for Drug Registration", "Regulations on the Management of On-site Inspection of Drug Registration", "Regulations on Drug Operation Quality Management" and other management documents of drug supervision and management, and organized and participated in the special inspection of drugs. There are more than 100 varieties of drug clinical trial data authenticity verification and unannounced inspections.