Regulatory Affairs Part I & II: The IND and NDA Phases

Learn about US Food and Drug Administration (FDA) regulations and expectations for the content, submission, and review of investigational new drugs (IND)/new drug applications (NDA) 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 organization relative to the development of pharmaceuticals and biologics in the US. Learn the processes characteristic of pharmaceuticals and biologic product discovery, development, and commercialization in the United States.

EVENT CODE:12427