The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires professionals have a good working knowledge, background and understanding of FDA’s most recent developments, trends and legislation affecting product development, licensing and manufacturing of current and future pharmaceutical products and devices. This course provides students with a broad background and understanding of the most current regulatory developments, strengthening their capacity to discuss and address contemporary issues effecting the pharmaceutical and medical device industry. The student will become familiar with the challenges posed by recent legislation and enforcement and be better able to analyze, plan and navigate in the dynamic and complex medical products industry. (ALS 463)
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