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Regulatory Science (RSCI)
Design and implementation of a quality system assuring the quality and safety of pharmaceuticals and biologics, according to relevant FDA and international regulations and guidance documents.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49105D | 626 | Lecture | TBA | TBA | 33 of 50 | Susan Bain,Eunjoo Pacifici | OFFICE & ONLINE |
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 | 22 of 50 | Susan Bain,Eunjoo Pacifici | OFFICE & ONLINE |
Historical development, formal language and theoretical approaches to risk management in health care and medical product environment; policies, regulations, standards; liability prevention and loss control. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience. (Duplicates credit in MPTX 520.) 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.
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49120D | 679 | Lecture | TBA | TBA | 30 of 50 | Keith Morel, Eunjoo Pacifici,Meredith Smith | 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 | 5 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | OFFICE & ONLINE | ||
49122D | 892 | Lecture | TBA | TBA | 5 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici | OFFICE & 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 | 22 of 50 | Hovhannes Gukasyan,Daryl Davies,Eunjoo Pacifici | OFFICE & 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 | Units | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
---|---|---|---|---|---|---|---|---|---|---|
49115D | 626 | 1.0-12.0 | Lecture | TBA | TBA | 24 of 50 | Eunjoo Pacifici | OFFICE | ||
49116D | 679 | 1.0-12.0 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici | OFFICE | ||
49117D | 624 | 2.0 | Lecture | TBA | TBA | 4 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | ONLINE |
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 | 4 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 |
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49137D | 626 | Lecture | TBA | TBA | 49 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici | OFFICE & ONLINE |
Regulatory strategy in EU, Canada, Mexico and South America; culture, health-care practices, reimbursement, product registration, quality systems, trade restrictions, import/export requirements. Travel may be required. . 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 |
---|---|---|---|---|---|---|---|---|---|
49138D | 572 | Lecture | TBA | TBA | 10 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici,Lawrence Liberti | 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 | 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 | 436 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici | ONLINE |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794A
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49146D | 436 | Lecture | TBA | TBA | 4 of 50 | Eunjoo Pacifici | ONLINE |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794B
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49147D | 436 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | ONLINE |
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 | 436 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | ONLINE |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794D
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49149D | 436 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici | ONLINE |
Preparation for the qualifying exam. Graded CR/NC
Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
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49144D | 436 | Lecture | TBA | TBA | 9 of 50 | Eunjoo Pacifici | ONLINE |