David L. Rosen, a partner and co-chair of the Life Sciences Industry Team of Foley & Lardner LLP will participate in presenting the Webcast, “Introduction to Drug and Medical Device Law” hosted by the The Regulatory Affairs Professionals Society. This course will provide an overview of how drugs and medical devices are regulated in the United States. Attendees will specifically:
Learn the basics concerning the laws and regulations that impact the pharmaceutical industry
Gain an understanding of the different statutory provisions and how they operate in reality
Get a sense of FDA’s organization, the history of drug regulation, and how new drugs, generic drugs and over-the-counter (OTC) drugs get into the marketplace
Learn the basics concerning the laws and regulations that impact the medical device industry
Get a sense of FDA’s organization, the history of medical device regulation and how new medical devices and substantially equivalent medical devices get in the market place and the post market requirements
Gain an overview of the Quality System Regulation (QSR), adverse events, and promotion and advertising
