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Risk Analysis In broad terms, risk analysis involves “the identification, analysis and minimization of risk” in the product development planning process, according to Elaine Whitmore. As she explains in this week’s Required Reading, the three major sources of medical product risk are product defects, side effects, and user error. To prepare for this Discussion, review this week’s Learning Resources on risk analysis and globalization and reflect on your knowledge of clinical trials. By Day 4, post a comprehensive response to the following: How does a clinical trial contribute to risk analysis? How is the task of risk analysis complicated by globalization? Read a selection of your colleagues’ postings. By Day 6, respond to at least one of your colleagues’ postings in one or more of the following ways: Ask a probing question. Expand on the colleague’s posting with additional insight and resources. Offer polite disagreement or critique, supported with evidence. In addition, you may also respond as follows: Offer and support an opinion. Validate an idea with your own experience. Make a suggestion or comment that guides or facilitates the discussion.

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