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Regulatory Science (RSCI)
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 | 892 | Lecture | TBA | TBA | 5 of 50 | Roger Clemens,Eunjoo Pacifici | OFFICE & ONLINE |  |
Management of medical product safety by manufacturers/suppliers, including: safe manufcturing, labeling, packaging; pharmacovigilance, field observations, complaint handling; record keeping, safety issues documentation; crisis management/recalls. 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49127D | 626 | Lecture | TBA | TBA | 11 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | OFFICE & ONLINE | |
Explores the activities involved in transformin an early drug or biological candidate to a drug approved for marketing by regulatory authorities. 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49132D | 626 | Lecture | TBA | TBA | 13 of 50 | Hovhannes Gukasyan,Eunjoo Pacifici,Tony Succar | 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 | 8 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | OFFICE | | |
| 49116D | 679 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | 5 of 50 | Eunjoo Pacifici | OFFICE | | |
| 49101D | 679 | Lecture | TBA | TBA | 5 of 50 | Eunjoo Pacifici | OFFICE | |
Statistical and research design methods, data analysis, survey and interview techniques laying the foundation for the dissertation
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49142D | 436 | Lecture | TBA | TBA | 10 of 50 | Terry Church,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 | 0 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | 0 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | 0 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | 0 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | 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 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | OFFICE | |
Preparation for the qualifying exam. Graded CR/NC
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49144D | 626 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici,Nancy Pire-Smerkanich,Susan Bain | OFFICE | |