This course examines the legal, business, regulatory, scientific and ethical issues raised by the fairly recent revolution in the United States and Chinese biotechnology research community and industry and its relevance to the pharmaceutical sector and each nation's health and welfare. The course is designed to provide Chinese and US law students with an overview of the essential tools that are necessary to become a biotechnology law and life sciences law practioner. Such areas consist of an overview of the science of biotechnology; intellectual property law including patents; patent litigation; university technology transfer policies and relations; government funding; private and public financing of biotechnology companies; licensing; research and development, collaborations and mergers and acquisitions activity with pharmaceutical companies; food and drug law and the regulations promulgated by the U.S. Food and Drug Administration (FDA) and the Chinese State Food and Drug Administration (SFDA); biodefense and infectious disease response issues; and bioethical concerns. Speakers will include officials from the Chinese office of the FDA and from the SFDA.
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