Overview
Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements
Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.
Course Level: Beginner
Feedback from Our Participant(s)
"This is the first DIA course I have taken and by far, the best I've ever taken. The instructors have a wealth of knowledge and experience with Regulatory Affairs and the FDA. A great class overall."
"This Regulatory class was the best course I've ever taken. A huge thanks to all for making it a valuable and wonderful experience!"
"This was a great beginner course in regulatory affairs. I learned a lot and was able to meet people from different companies."
"A very throughtout course. Recommended also for people without a pharmaceutical background."
"Course exceeded my expectations. It was informative, intersting, interactive and relevant to my work. The instructors were very good, and provided many examples that brought the learning materials to life."
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