Who Should Attend
Personnel in the pharmaceutical, biotechnology and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) will find this course to be of particular benefit. Those who need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel will also find this course extremely useful.
Learning Objectives
By the end of this course, attendees will:
- Understand the importance and underlying principles of the FDA drug development process from Phase 1 IND through market approval
- Learn how to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas
- Learn how to effectively prepare for and communicate during meetings with the FDA
- Fully understand the ramifications of filing incomplete or incorrect submissions
Course Description
This course will give participants the background and history of the US Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Each item of these submissions will be individualized, analyzed, and discussed in conjunction with their importance in relation to FDA regulations and guidances. Each item will be detailed as to how to best present data for successful FDA approvals.
Course content will include preparation for FDA meetings and the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be covered. The Common Technical Document (CTD) formatting will also be discussed.