| Taking Devices and Pharmaceuticals To Market. IEEE EMBS. Taking a human therapeutic product to market involves a lot of technical, legal and business challenges, whether it is a pharmaceutical, a biological or a medical device. Everyone in the life sciences is aware at some level that a new product must obtain the approval of the Federal Food and Drug Administration, but not everyone is aware of the challenges that can arise in securing approvals for payment by Medicare and insurance companies and in complying with regulatory requirements for manufacturing and distribution of products. This session will provide a very broad overview of the regulatory process involved in taking a potential therapeutic product from the development laboratory to a commercial product, with a focus on identifying the planning, timetables, and decisions necessary for a successful life sciences business. See http://embs.ieee-bv-cs.org/ |
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