Overview
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Attend this live, virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs and NDAs, post-marketing requirements, and the importance of regulatory strategy throughout the product lifecycle. This high-level but comprehensive course employs a blend of real-world examples, interactive lectures, workshops, and online pre-course modules. This basic to intermediate training course focuses on prescription drugs (primarily small molecules) and well-characterized biological products. The requirements specific to generic drugs, traditional biologics, biosimilars, devices, and OTC monograph products are not covered in detail. However, many of the regulations, principles, and processes described in this course will apply to these types of products. View the detailed agenda.
Can't attend this live virtual offering? Register for the on demand version of this course.
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