Training & Education

　　　In addition to its own expertise (such as medical science, pharmaceutics, pharmacology, toxicology, statistics, biotechnology, Chinese herbal medicine etc), an effective reviewer also needs knowledge and the accumulated experience in the related fields of drug review guidelines. Due to the talents are rare and difficult to recruit, CDE has taken efforts to provide on-job training in various areas of tasks.

　　　New coming members’ orientation training includes: Comprehensive summary of new drug developmental process, IND Process, Application of clinical trial protocol, New Drug Application, Chinese herbal medicine and biotechnology categories products, statistic, and the review process with related guidelines as described above. Then focus on individual’s discipline, CDE provides one to one advanced training.

　　　The courses of on-job training includes pharmaceutical regulatory guidelines, Development of Chinese herbal medicines, biological products, bridging study, pharmacokinetics / pharmacodynamics, biostatistics, and others related to the drug review. Reviewers at CDE also gained their training through invited speaker’s lecture, attending domestic/international conference and taking short course at renowned international pharmaceutical companies.

　　　Driven by DOH commission to manage gene therapy and other advanced biotechnologies, as well as the GCP inspection on Chinese herbal medicine, CDE is providing new training courses to meet the demand.