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Regulatory Science (RSCI)
Design of systems according to FDA and international regulations and guidelines to ensure the quality and safety of medical devices and combination products.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49109D | 626 | Lecture | TBA | TBA | 13 of 50 | Susan Bain, Eunjoo Pacifici | OFFICE & ONLINE | ![]() |
Current problems in regulatory affairs, legal management, preclinical and clinical testing, scientific evaluation and quality assurance. (Duplicates credit in former MPTX 521.) Graded CR/NC. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post secondary training and industry experience; enrollment in MS Regulatory Science program.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49121D | 626 | Lecture | TBA | TBA | 0 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | ONLINE | ![]() | |
49122D | 892 | Lecture | TBA | TBA | 22 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich, Frances Richmond, Susan Bain | ONLINE | ![]() | |
49123D | 695 | Lecture | TBA | TBA | 8 of 50 | Eunjoo Pacifici,Frances Richmond, Nancy Pire-Smerkanich, Keith Morel | ONLINE | ![]() |
Factors affecting toxic responses to foods and drugs: dose-response relationships, absorption, distribution, biotransformation, elimination of toxicants; target organ toxicity, teratogenesis, mutagenesis, carcinogenesis, food allergies, risk assessment. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49125D | 626 | Lecture | TBA | TBA | 7 of 50 | Roger Clemens, Eunjoo Pacifici | ONLINE | ![]() |
Examines the process of drug discovery from selection of disease and therapeutic target to characterization and validation of lead drug candidates. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in M.S., Regulatory Science, certificate in Preclinical Drug Development.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49131D | 626 | Lecture | TBA | TBA | 16 of 50 | Daryl Davies,Eunjoo Pacifici | OFFICE & ONLINE | ![]() |
Survey of drug development strategies; health economics and outcomes researches and reimbursements; emphasis on coverage determination process and FDA and CMS parallel review process
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49124D | 626 | Lecture | TBA | TBA | 7 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | ONLINE | ![]() |
Research leading to the master's degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49115D | 626 | Lecture | TBA | TBA | 6 of 50 | Eunjoo Pacifici | OFFICE & ONLINE | ![]() | |
49116D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE | ![]() |
Part-time or full-time practical work experience in Regulatory Science. The internship must be located at an off-campus facility. Students are individually supervised by faculty. Graded CR/NC. Recommended preparation: Undergraduate or professional degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science).
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49100D | 626 | Lecture | TBA | TBA | 8 of 50 | Eunjoo Pacifici | OFFICE | ![]() | |
49101D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE | ![]() |
Introduction to business principles appropriate to medical products, including: supply and demand, product entry-exit strategies, financing, reimbursement, marketing and pricing in global marketplace. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in M.S., Regulatory Science.
- Restriction: Registration open to the following major(s): Regulatory Science
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
---|---|---|---|---|---|---|---|---|---|
49137D | 626 | Lecture | TBA | TBA | 31 of 50 | Frances Richmond, Eunjoo Pacifici,Nancy Pire-Smerkanich | ONLINE | ![]() |
Theory and methods to manage complex projects in medical products sectors; timelines, intellectual property, security, contracts, budgets, review activities, reports, electronic tools, cross-cultural communication. Recommended preparation: Undergraduate or professional degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49138D | 695 | Lecture | TBA | TBA | Canceled | Frances Richmond, Eunjoo Pacifici | TBA | ![]() | |
49139D | 626 | Lecture | TBA | TBA | 14 of 50 | Frances Richmond, Eunjoo Pacifici | ONLINE | ![]() |
Research leading to the doctorate. Maximum units which may be applied towards the degree to be determined by the department. Graded CR/NC
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49118D | 626 | Lecture | TBA | TBA | 1 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Dissertation research required for completion of doctoral degree in Regulatory Science.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49145D | 626 | Lecture | TBA | TBA | 3 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794A
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
---|---|---|---|---|---|---|---|---|---|
49146D | 626 | Lecture | TBA | TBA | 8 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794B
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
---|---|---|---|---|---|---|---|---|---|
49147D | 626 | Lecture | TBA | TBA | 0 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794C
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49148D | 626 | Lecture | TBA | TBA | 0 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794D
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
---|---|---|---|---|---|---|---|---|---|
49149D | 626 | Lecture | TBA | TBA | 0 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |
Preparation for the qualifying exam. Graded CR/NC
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49144D | 626 | Lecture | TBA | TBA | 10 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE | ![]() |