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    Walden University
  Dec 15, 2017
2017-2018 Catalog (September 2017)
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CLRA 6205 - Product Development in the Pharmaceutical, Biotechnology, and Medical Device Industries♦

(3 sem. cr.) In this course, students examine current trends and issues in the pharmaceutical, biotechnology, and medical device industries, focusing on how the commercial enterprise uses clinical research to bring products to market through the clinical development and regulatory process. They examine the process by which discoveries become new drugs or medical devices, the preclinical process, and the development of the clinical research plan, and they consider new drug and medical device applications, pre-market approvals, marketing authorizations, and post-marketing surveillance. Through discussions and practical assignments, students consider a variety of topics, including pharmacogenomics, pharmacoepidemiology, recent safety concerns of regulators, globalization, the politics of drug pricing and healthcare reimbursement, product life-cycle management, outsourcing of studies to developing countries, patent strategies, and accelerated approval of medications. They also analyze case studies representing several therapeutic categories from multiple perspectives, including business, medical, scientific, ethical, regulatory, and biomedical engineering.
♦ Students may take this as a non-degree course, which means they do not have to be enrolled in a program. Contact an Enrollment Advisor [1-866-492-5336 (U.S.);1-443-627-7222 (toll)] for more information.

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