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| ABE 51400 - Documents And Dialogues Of Drug Development And Registration |
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Credit Hours: 3.00. This capstone advanced course will integrate previous learning relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for preclinical research clinical trials and new drug approvals. Special topic lectures will be given. Considerable time will be devoted to preparing regulatory documents and conducting "mock" dialogues and negotiations with "pretend" agency officials.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture, Recitation Offered By: College of Agriculture Department: Ag & Biological Eng Program Course Attributes: Dept Credit, Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette 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). Restrictions: Must be enrolled in one of the following Programs: Agric Biol Engr-MS-ABE Must be enrolled in one of the following Levels: Graduate Must be enrolled in one of the following Concentrations: Biotech Innov & Regulatory Sci Prerequisites: ABE 51100 and ABE 51200 |
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