Who Should Attend
This three-day course is geared for those who assemble, supervise, or manage the preparation and submission of Abbreviated New Drug Applications (ANDAs). Professionals in regulatory, analytical, quality, development and manufacturing groups will also find this course suitable. Additionally, the course will benefit those in other departments who are required to provide information to be incorporated into submission documents.
Upon completion of this course attendees will:
- Have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively plan and gather required documentation and assemble an ANDA
- Have learned how to organize their company and develop timelines to assure that the ANDA is filed on time
- Have gained practical knowledge regarding the development of templates and checklists to assure completeness of the application
- Have gained the information necessary to prepare the ANDA in either paper or electronic format for final submission.