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| TLI 52200 - Good Regulatory Practice |
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Credit Hours: 3.00. Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, and good clinical practices. The meaning of these regulations, the globalization of practices, and the roles and responsibilities of various professionals implementing these regulations are addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company. Typically offered Fall Spring Summer.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture, Recitation Offered By: College of Technology Department: Technology Ldrshp & Innovatn Course Attributes: Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette Learning Outcomes: 1. Understand the conceptual foundations and approaches to good regulatory practices and comprehend strategies used in regulatory affairs. 2. 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). 3. Ability to meld theory and practice in regulatory affairs. 4. 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. 5. Read, write, speak, listen, and use data, media and computers to send and respond effectively to communication for varied audiences and purposes. 6. Demonstrate sensitivity to and facility with personal values and ethical principles in professional and social contexts. 7. Recognize the factors that influence regulatory decisions, develop methods to incorporate regulatory trends and practices, and think strategically about product development and marketing. 8. Examine quality systems and standards and their impact on public safety as well as the reliance on quality by health care providers. 9. 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 Colleges: Graduate School College of Pharmacy Doctor of Pharmacy May not be enrolled as the following Classifications: Junior: 75 - 89 hours Professional First Year Freshman: 15 - 29 hours Sophomore: 30 - 44 hours Sophomore: 45 - 59 hours Junior: 60 - 74 hours Freshman: 0 - 14 hours Prerequisites: Graduate level TLI 52100 Minimum Grade of D- |
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