Submissions to a regulatory agency such as the FDA involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.
In this practical course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), marketing (NDA/CTD) and post-marketing documents. Students also gain experience with tools that help manage timelines and sections needed from contributors.
Note(s):To get the most from this course, students should have strong English communication skills and ready access to a computer.