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Regulatory Science (RSCI)
Fundamentals and applications of Statistical Process Control (SPC) in development and monitoring of manufacturing processes; includes SPC in root cause analysis and CAPA.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49107D | 679 | Lecture | TBA | TBA | 31 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49121D | 626 | Lecture | TBA | TBA | 2 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | OFFICE & ONLINE | | |
| 49122D | 892 | Lecture | TBA | TBA | 13 of 50 | Nancy Pire-Smerkanich,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 | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49115D | 626 | Lecture | TBA | TBA | 14 of 50 | Eunjoo Pacifici,Susan Bain,Nancy Pire-Smerkanich | OFFICE | | |
| 49116D | 679 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici,Susan Bain,Nancy Pire-Smerkanich | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49100D | 626 | Lecture | TBA | TBA | 4 of 50 | Eunjoo Pacifici | OFFICE | | |
| 49101D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE | |
Regulatory policy, standards and practices in different Asian markets: product licensing, import/export management, materials sourcing, quality systems compliance, reimbursement, prescribing practices. 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49139D | 626 | Lecture | TBA | TBA | 11 of 50 | Eunjoo Pacifici,Frances Richmond,Chiaoyun Kuo | OFFICE & ONLINE | |
Policies, testing and regulatory requirements affecting commercialization of biologics and novel medical technologies. Focus on biologics, blood and tissue products, radiopharmaceuticals and nanotechnology
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49141D | 626 | Lecture | TBA | TBA | 23 of 50 | Nancy Pire-Smerkanich,Susan Bain,Eunjoo Pacifici | OFFICE & 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49118D | 626 | Lecture | TBA | TBA | 2 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49145D | 626 | Lecture | TBA | TBA | 4 of 50 | 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 | 1 of 50 | 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 | 1 of 50 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49148D | 626 | Lecture | TBA | TBA | 1 of 50 | 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 | 1 of 50 | Eunjoo Pacifici | OFFICE | |
Preparation for the qualifying exam. Graded CR/NC
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49144D | 626 | Lecture | TBA | TBA | 9 of 50 | Eunjoo Pacifici | OFFICE | |