The Center for Professional Innovation & Education, Malvern, PA
10/27/08
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) or who will need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel.
Learning Objectives
- 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
- Understand the seriousness that the FDA takes its responsibilities
Course Description
This course will give the participants the background and history of the 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 the data for successful FDA approvals.
The course content will include preparing for FDA meetings and discuss all 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 be discussed.
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