Written Project Requirements:

Choose you case study!

1.Scientific component (not less than 1 page)

•What was the compound used for;

•What caused the problem/tragedy (adverse reaction, drugs interactions, etc.).

2.Identify and describe the problem from public side. What happen? (not less than 1 page).

3.Describe the consequence of the steps that led to the problem/tragedy. Include information about both the company and the regulatory agency; (not less than 1 page).

4.Imagine, you are a Project Manager inside the company working on this project. What would you do differently? (not less than 1 page).

5.Imagine, you are a Project Manager at the FDA (other regulatory agencies). Your steps? (not less than 1 page).

Can you imagine this situation happening in 2015? Why?

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