Regulatory Affairs Part I: The IND Phase

Learn about US Food and Drug Administration (FDA) regulations and expectations for the content, submission, and review of investigational new drugs (INDs) and the importance of regulatory strategy. This blended learning opportunity features two archived online courses focusing on fundamental concepts, followed by a training course consisting of interactive lectures and hands-on workshops. Learn about FDA history, regulations, roles and responsibilities, and organizations relative to the development of pharmaceuticals and biologics in the United States. Learn the processes characteristic of pharmaceuticals and biologic product discovery, development, and commercialization in the United States.

EVENT CODE:12431