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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 |
|---|---|---|---|---|---|---|---|---|---|
| 49105D | 626 | Lecture | TBA | TBA | 23 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49109D | 626 | Lecture | TBA | TBA | 16 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49120D | 679 | Lecture | TBA | TBA | 15 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49121D | 626 | Lecture | TBA | TBA | 8 of 50 | Chiaoyun Kuo, Eunjoo Pacifici | OFFICE & ONLINE | | |
| 49122D | 892 | Lecture | TBA | TBA | 15 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49131D | 626 | Lecture | TBA | TBA | 22 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49124D | 626 | Lecture | TBA | TBA | 11 of 50 | Chiaoyun Kuo, 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 | 10 of 50 | Eunjoo Pacifici,Susan Bain,Nancy Pire-Smerkanich | OFFICE | | |
| 49116D | 679 | Lecture | TBA | TBA | 0 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 | 6 of 50 | Eunjoo Pacifici | OFFICE | | |
| 49101D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE | |
Special topics in Regulatory Science
| Section | Session | Units | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|---|
| CGMP/QSR Validation Principles for Medical Products | ||||||||||
| 49134D | 695 | 2.0 | Lecture | TBA | TBA | 7 of 50 | Susan Bain,Eunjoo Pacifici | OFFICE & ONLINE | | |
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 | 50 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici | OFFICE & 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 |
|---|---|---|---|---|---|---|---|---|---|
| 49138D | 695 | Lecture | TBA | TBA | 16 of 50 | Frances Richmond,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 | 1 of 50 | Eunjoo Pacifici,Susan Bain,Nancy Pire-Smerkanich | 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 | 1 of 50 | Eunjoo Pacifici,Frances Richmond | 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,Frances Richmond | 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,Frances Richmond | 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,Frances Richmond | 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,Frances Richmond | OFFICE | |
Preparation for the qualifying exam. Graded CR/NC
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49144D | 626 | Lecture | TBA | TBA | 10 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |