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| ABE 51400 - Documents And Dialogues Of Drug Development And Registration |
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Associated Term:
Spring 2020
Learning Outcomes: 1. Obtain and apply broad knowledge of FDA and international law, regulations, and guidance documents for at least one category of medical products (drugs, biological products, devices). 2. Ability to meld theory and practice in regulatory affairs. 3. Examine issues rationally, logically, and coherently; and acquire, evaluate, and synthesize information and knowledge relevant to an identified problem; and make sound decisions in both familiar and unfamiliar contexts. 4. Read, write, speak, listen, and use data, media and computers to send and respond effectively to communication for varied audiences and purposes. 5. Recognize the factors that influence regulatory decisions, develop methods to incorporate regulatory trends and practices, and think strategically about product development and marketing. 6. Obtain and apply broad knowledge of FDA and international requirements for the approval and conduct of pre-and post-market clinical studies with regulated products and understand the basic principles of clinical study design and clinical data analysis for at least one category of medical products (drugs, biological products, devices). Required Materials: Technical Requirements: |
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