This course provides in depth knowledge and hands-on work with various types of regulatory submissions. The completion and applications of regulatory submissions such as CTA, NDS/A, ANDS/A, and CTD are discussed in details. There is an in-depth discussion of the regulatory review process. Strategies on how to have a successful submission is discussed in details.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.
The course objective is the learn about the requirements for Non-clinical studies in support of producing regulatory filings to proceed to human clinical trials. The documentation and study requirements will be reviewed in the context of global submission in the CTD format.