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.



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Past Participant's Comments:

“Very personable Course Director.  Held the attention of the class.  Very well-organizaed and prepared.  Course Notes were well organized.  Able to handle questions well and present ‘real-life’ experiences.”
Angela S., Medical Writer, Abbott Laboratories

“Always nice to see actual or mock documents of how things look eCTD, CTD, slides of pre IND meeting examples.  Thank you so much, the course was very well done!”
Tammy L., Regulatory Affairs Senior Manager, Ultradent Products

“This course gave a great overview and insight into requirements for submissions and working with the FDA.  The Course Director’s experience provided additional insight that was appreciated!”
Amy H., Regulatory Affairs Manager, Cardinal Health

“Very comprehensive and easy to understand!”
Carl D., Team Leader of Regulatory Affairs, The Dial Corp.

“The speaker was superior.  Seldom do I go to a course where the speaker does not read the overheads word for word.  Super Super Super!”
Chandler W., Manager, Analytical Services, Stability Group

“The Course Director articulated his ideas and the course content in a manner that was concise and interesting.  This was the best course and instructor that I have been exposed to thus far.  Excellent speaker…great job!”
Lynn C., Regulatory Affairs Associate, Biomira, Inc.

“Great balance of overview of a high amount of material, but also a lot of specific, practical advice.”
Sean O., QA/Regulatory Compliance, MD Andersen