The course goal is to provide you with the right skills to handle properly pharmaceutical CTD files. It covers all the areas of knowledge that a person needs to be a successful regulatory personnel such as how to review & fill up module one of the CTD file based on ICH guidelines (ex. using JFDA & Gulf M1 forms) with practical application, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable.