The course schedule is provided to help keep you informed about the latest program offerings. This information is subject to change, though changes occur infrequently. In such an instance, students will be informed. To ensure that you have the latest information on course offerings, we recommend you check this page before scheduling other activities. All courses require Department Clearance (D-Clearance) and can be requested here.
Click here to view the main Schedule of Classes and note important Add/Drop dates.
Schedules are tentative.
| MPTX 511 | 3 | Introduction to Medical Product Regulation | Sunday, August 27, 2023 Sunday, September 24, 2023 Sunday, October 1, 2023 Sunday, October 22, 2023 Sunday, November 19, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 513 | 3 | Regulation of Medical Devices and Diagnostics | Sunday, August 20, 2023 Sunday, September 10, 2023 Saturday, October 21, 2023 Saturday, November 4, 2023 Saturday, November 18, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 516 | 3 | Medical Products and the Law | Sunday, August 27, 2023 Sunday, September 24, 2023 Sunday, October 8, 2023 Sunday, November 19, 2023 Saturday, December 2, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 517 | 4 | Structural and Management of Clinical Trials | Saturday, August 19, 2023 Saturday, September 16, 2023 Saturday, October 14, 2023 Saturday, November 4, 2023 Saturday, November 18, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 518 | 3 | Writing Regulatory Submissions | Monday, August 21, 2023 – EveningZoom Saturday, September 9, 2023 Sunday, September 17, 2023 Sunday, September 24, 2023 Sunday, October 1, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 526 | 3 | Chemistry and ManufacturingControls | Saturday, August 26, 2023 Saturday, September 23, 2023 Sunday, October 8, 2023 Sunday, October 29, 2023 Sunday, November 5, 2023 | 9:00am‐5:00pm HSC/CHP |
| MPTX 630 | 6 | Directed Field‐Research | August ‐ December | |
| RSCI 507 | 2 | Quality Systems and Statistical ProcessControl | Saturday, October 14, 2023 Sunday, October 15, 2023 Saturday, November 4, 2023 Sunday, November 5, 2023 | 9:00am‐5:00pm HSC/CHP |
| RSCI 521/49121 | 1 | Journal Club | Wednesdays, August 23, 2023 ‐December 6, 2023 (15 sessions) | 12:00pm‐1:00pm HSC/CHP |
| RSCI 521/49122 | 1 | CTSI Symposium w/RSCI 606 | Friday, October 20, 2023 | 9:00am‐5:00pm HSC/CHP |
| RSCI 590 | 1‐3 | Directed Research | August ‐ December | |
| RSCI 596 | 1 | CPT | August ‐ December | |
| RSCI 604 | 4 | Regulatory Strategy in Asia (DRSc only) | November 5 ‐ November 16, 2023 | |
| RSCI 606 | 3 | Regulation of Emerging Technologies and Biological Products | Saturday, August 19, 2023 Saturday, September 9, 2023 Saturday, September 30, 2023 Friday, October 20, 2023 (CTSI Symposium w/RSCI 521_49122) Sunday, November 19, 2023 | 9:00am‐5:00pm HSC/CHP |
| RSCI 790 | 1‐3 | Directed Research | August ‐ December | |
| RSCI 794a‐z | 0‐2 | Doctoral Dissertation | August ‐ December | |
| RSCI 800 | 0 | Studies for the Qualifying Exam | August – December |
| Course | Units | Title | Dates | Location |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | Friday, May 19, 2023 Friday, June 2, 2023 Sunday, June 4, 2023 Sunday, July 9, 2023 Sunday, July 30, 2023 | 9:00am-5:00pm HSC/CHP |
| MPTX 512 | 3 | Regulation of Pharmaceutical and Biological Products | Wednesday, May 17, 2023 – Chat session 6:30-7:30 pm* Saturday, May 20, 2023 Sunday, May 21, 2023 Wednesday, May 31, 2023 – Chat session 6:30-7:30 pm* Saturday, June 3, 2023 Sunday, June 4, 2023 Saturday, June 17, 2023 | 9:00am-5:00pm HSC/CHP* |
| MPTX 513 | 3 | Regulation of Medical Devices and Diagnostics | Saturday, May 20, 2023 Saturday, June 10, 2023 Saturday, June 24, 2023 Friday, July 14, 2023 Friday, July 28, 2023 | 9:00am-5:00pm HSC/CHP |
| MPTX 514 | 3 | Regulation of Foods and Dietary Supplements | Saturday, May, 13, 2023 Saturday, June 3, 2023 Saturday, June 17, 2023 Saturday, July 8, 2023 Saturday, July 29, 2023 Thursday, July 27, 2023 – Field Trip (Amway/Nutrilite) | TBA |
| MPTX 515 | 3 | Quality Systems and Standards | Friday, May 19, 2023 Friday, June 9, 2023 Friday, June 23, 2023 Saturday, July 15, 2023 Saturday, July 29, 2023 | 9:00am-5:00pm HSC/CHP |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | Friday, July 21, 2023 Saturday, July 22, 2023 Sunday, July 23, 2023 Monday, July 24, 2023 | 9:00am-5:00pm HSC/CHP |
| MPTX 602 | 2 | Science, Research and Ethics | Saturday, June 24, 2023 Sunday, June 25, 2023 Wednesday, July 12, 2023 – Chat session 5:00-6:00 pm* Saturday, July 15, 2023 Wednesday, July 26, 2023 – Chat session 5:00-6:00 pm* Saturday, July 29, 2023 Wednesday, August 2, 2023 – Chat session 5:00-6:00 pm* | 9:00am-5:00pm HSC/CHP* |
| MPTX 630 | 6 | Directed Field-Research | May – August | |
| RSCI 521/49122 | 1 | Special session w/MPTX 514 | Saturday, July 29, 2023 Thursday, July 27, 2023 (Field Trip – Amway/Nutrilite Tour) | TBA |
| RSCI 532 | 3 | Early Stage Drug Development | Sunday, May 14, 2023 Sunday, May 21, 2023 Sunday, June 11, 2023 Sunday, July 9, 2023 Sunday, July 23, 2023 | 9:00am-5:00pm HSC/CHP* |
| RSCI 590 | 1-3 | Directed Research | May – August | |
| RSCI 596 | 1 | CPT | May – August | |
| RSCI 790 | 1-3 | Directed Research | May – August | |
| RSCI 794a-z | 0-2 | Doctoral Dissertation | May – August | |
| RSCI 800 | 0 | Studies for the Qualifying Exam | May – August |
| Course | Units | Title | Dates | Location |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | January 8, 20; February 12, March 5; April 16 | 9:00am-5:00pm HSC/CHP |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | January 22; February 4, 25; March 19; April 2 | 9:00am-5:00pm HSC/CHP |
| MPTX 519 | 3 | Global Regulation of Medical Products | January 22; February 26; March 12, 26; April 15 | 9:00am-5:00pm HSC/CHP |
| MPTX 522 | 3 | Introduction to Clinical Trial Design and Statistics | January 21; February 12; March 10’ April 1, 23 | 9:00am-5:00pm HSC/CHP |
| RSCI 508 | 3 | Quality Assurance for Drugs and Biologics | January 28; February 5; March 11, 24; April 15 | 9:00am-5:00pm HSC/CHP |
| RSCI 509 | 3 | Quality Assurance for Medical Products and Combination Products | January 29; February 4; March 12, 25; April 16 | 9:00am-5:00pm HSC/CHP |
| RSCI 520 | 2 | Introduction to Risk Management for Healthcare Products | March 4, 5, 18; April 1 | 9:00am-5:00pm HSC/CHP |
| RSCI 521/49121 | 1 | Journal Club | Weekly, Wednesdays ONSITE: January 18, February 15, March 22, April 19 (all remaining dates remote) | 12:00-1:00pm HSC/CHP |
| RSCI 521/49122 | 1 | CTSI Seminar (w/522) | March 10 | 9:00am-4:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology | January 21; February 4; March 4; April 15, 22 | 9:00am-5:00pm HSC/CHP |
| RSCI 531 | 4 | Drug Discovery | January 7, 29; February 26; March 19, 26; April 23 | 9:00am-5:00pm HSC/CHP |
| RSCI 541 | 3 | Medical Product Development, Reimbursement | January 22, February 12 (Zoom), March 5 (Zoom), March 26, April 16 | 9:00am-5:00pm HSC/CHP |
| RSCI 590 | 1-3 | Directed Research | January – April | |
| RSCI 596 | 1 | CPT | January – April | |
| RSCI 599 | 2 | Validation Requirements for Medical Products | January 7, 8; February 25 | 9:00am-5:00pm HSC/CHP |
| RSCI 601 | 4 | Biomedical Commerce | January 8, 28; February 11; March 11; April 22 | 9:00am-5:00pm HSC/CHP |
| RSCI 603 | 3 | Managing Complex Projects | January 7, 21, 28, 29; February 25 | 9:00am-5:00pm HSC/CHP |
| Course | Units | Title | Dates | Location |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | August 19, 27, September 16, October 23, November 18 | 9:00am-5:00pm HSC/CHP |
| MPTX 513 | 3 | Regulation of Medical Devices | August 20, September 18, October 8, 29, November 12 | 9:00am-5:00pm HSC/CHP |
| MPTX 516 | 3 | Medical Products and the Law | August 21, September 18, October 2, 16, November 20 | 9:00am-5:00pm HSC/CHP |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | August 28, September 17, October 15, November 5, 19 | 9:00am-5:00pm HSC/CHP |
| MPTX 518 | 3 | Writing Regulatory Submissions | August 20, September 10, 24, October 1, 9 | 9:00am-5:00pm HSC/CHP |
| MPTX 526 | 3 | Chemistry and Manufacturing Controls | August 28, September 17, 24, October 21, December 3 | 9:00am-5:00pm HSC/CHP |
| RSCI 506 | 3 | Auditing Principles | October 16, 30, November 5, 13, December 3 | 9:00am-5:00pm HSC/CHP |
| RSCI 507 | 2 | Quality Systems and Statistical Process Control | October 15, 22, November 12, 13 | 9:00am-5:00pm HSC/CHP |
| RSCI 521 | 1 | Journal Club | Wednesdays Aug. 24-Dec. 7 | 12:00pm-1:00pm |
| RSCI 521/506 | 1 | Auditing Principles | October 16, October 30 (Topic TBD), November 5 (Topic TBD), 13 (Topic TBD) | 9:00am-5:00pm HSC/CHP |
| RSCI 521/606 | 1 | CTSI Symposium (Topic TBD) | September 23 | 9:00am-4:00pm HSC/TBD |
| RSCI 521/599 | 1 | Special Topic (w/Industry) | September 30 | 9:00am-4:00pm HSC/TBD |
| RSCI 533 | 3 | Safety Evaluation During Drug Development | August 28, September 25, October 22, 23, November 20 | 9:00am-5:00pm HSC/CHP |
| RSCI 599 | 3 | Validation Requirements for Medical Products | September 24, 25, 30, October 1, 9 | 9:00am-5:00pm HSC/CHP |
| RSCI 604 | 4 | Regulatory Strategy in Asia (DRSc only) | October 30-November 12 | |
| RSCI 605 | 3 | Managing Organizations and Human Resources (DRSc only) | October 14-October 17 (cruise) Thursday evenings on Zoom (6pm PST) | |
| RSCI 606 | 3 | Regulation of Emerging Technologies and Biological Products | August 21, September 11 (tentative), 23, October 2, 23, November 6 | 9:00am-5:00pm HSC/CHP |
| RSCI 590 | 1-3 | Directed Research | ||
| RSCI 596 | 1 | CPT |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | May 14, 20, June 11, 24, July 23 | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | May 15, 21, 22, June 4, 5 | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices | May 15, June 4, 26, July 10, 30 | 9:00am-5:00pm |
| MPTX 514 | 3 | Regulation of Food and Dietary Supplements | May 21, June 12, 26, July 10, 24 | 9:00am-5:00pm |
| MPTX 515 | 3 | Quality Systems and Standards | May 14, June 5, 25, July 9, 31 | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | July 9, 16, 23, 30, 31 (Pre-course assignments before first day) | 9:00am-5:00pm |
| MPTX 602 | 2 | Science, Research and Ethics | June 25, 26, July 17, 31 | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar TBD (w/527) | TBD | TBD |
| RSCI 527 | 3 | Medical Product Safety | May 25 (Zoom, 6-8 pm), June 1 (Zoom, 6-8 pm), June 11, 12, 29 (Zoom, 6-8 pm), July 6 (Zoom, 6-8 pm), July 17 | 9:00am-5:00pm |
| RSCI 532 | 3 | Early Stage Drug Development | May 15, 22, June 5, 18, July 10 | 9:00am-5:00pm |
| RSCI 590 | 1-3 | Directed Research | May – July |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | January 9, 30, February 6, March 6, April 10 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | January 16, 29, February 12, March 5, April 30 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 519 | 3 | Global Regulation of Medical Products | January 23, February 27, March 13, 20, April 24 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 522 | 3 | Introduction to Clinical Trial Design and Statistics | January 22, February 4, 27, March 12, May 1 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 508 | 3 | Quality Assurance for Drugs and Biologics | January 8, February 5, March 12, April 10, 30 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 509 | 3 | Quality Assurance for Medical Devices and Combination Products | January 9, February 6, March 13, April 9, May 1 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 520 | 2 | Introduction to Risk Management for Healthcare Products | March 5, 6, March 20, April 10 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 (49121) | 1 | Seminar in Regulatory Science – Journal Club | Every Wednesday, Jan. 12-Apr. 27 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 521 (49122) | 1 | Seminar in Regulatory Science – CTSI Symposium (Topic TBD) | February 4 (w/522) (HSC, PSC) | 9:00am-5:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology | January 15, February 12, March 19, April 2, 9 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 531 | 4 | Drug Discovery | January 9, 29, February 13, March 6, 27, April 24 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 590 | 3 | TRAQS Project | January – April (HSC, CHP) | 9:00am-5:00pm |
| RSCI 590 | 1-3 | Directed Research | January – April (HSC, CHP) | 9:00am-5:00pm |
| RSCI 596 | 1 | CPT | January – April (HSC, CHP) | 9:00am-5:00pm |
| RSCI 601 | 4 | Biomedical Commerce | January 15, 30, February 26, March 19, April 16 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 603 | 3 | Managing Complex Projects (DRSc and RMGT only) | January 8, 16, 28, February 5, 13 (HSC, CHP) | 9:00am-3:00pm |
| RSCI 608 | 4 | Regulatory Strategy in Europe and the Americas (DRSc only) | Tentative travel: March 26-April 4, additional one or two session TBD |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | August 21, 29, September 12, October 17, November 14 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices | August 21, September 11, October 9, 30, November 13 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 516 | 3 | Medical Products and the Law | August 29, September 12, October 3, November 7, 21 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | August 28, September 18, October 16, November 6, 20 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 518 | 3 | Writing Regulatory Drug SubmissionsONLINE | August 21, September 19, October 2, 23, December 5 | 9:00am-5:00pm |
| MPTX 526 | 3 | Chemistry and Manufacturing Controls | August 29, September 18, October 9, 24, November 7 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 506 | 3 | Auditing PrinciplesONLINE | October 17, 30, November 7, 21, December 4 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 507 | 2 | Quality Systems and Statistical Process ControlONLINE | October 16, 23, November 13, 14 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal ClubONLINE | Wednesdays, August 25- December 8 | 12:00pm-1:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Auditing Principles (w/506)ONLINE | Students must attend the first class of RSCI 506 and attend one of the following:GLP (October 17, October 30)GMP (October 17, November 7)GCP (October 17, November 21) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Symposium “Innovation to Translation: Role of Genomics in Medical Product Development” (w/606) | September 24 (ONLINE) | 9:00am-4:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Computer System Validation Short Course “Unraveling the Mysteries of Computer System Validation (CSV)” | September 25 (ONLINE) | 9:00am-4:30pm |
| RSCI 599 | 3 | Validation Requirements for Medical Products –ONLINE | August 22, September 12, 25, October 2, 10 | 9:00am-5:00pm |
| RSCI 606 | 3 | Regulation of Emerging Technologies and Biological Products | August 27, September 18, 24, November 14, 21 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 607 | 4 | Theory, Methods, and Practice of Medical Products Research – DRSc course onlyONLINE | September 12, 19, October 10, 17, 31, November 13DRSc students on campus Friday-Monday – October 1, 2, 3, 4 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 590 | 1-3 | Directed Research | ||
| RSCI 596 | 1 | CPT |
| MPTX 511 | 3 | Introduction to Medical Product Regulation | May 15, June 6, 13, July 11, 25 | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | May 16, 22, 23, 29, June 6 | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices | May 22, June 6, 26, July 18, 31 | 9:00am-5:00pm |
| MPTX 514 | 3 | Regulation of Food and Dietary Supplements | May 22, June 12, July 10, 24, August 6 | 9:00am-5:00pm |
| MPTX 515 | 3 | Quality Systems and Standards | May 23, June 5, 27, July 17, August 1 | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | July 17, 18, 24, 25, 31 | 9:00am-5:00pm |
| MPTX 602 | 2 | Science, Research and Ethics | June 5, 19, July 10, 11 | 9:00am-5:00pm |
| RSCI 521 | 1 | Regulatory Science SeminarTopic: “Pharmacovigilance” This course is not recommended for students who attended the Pharmacovigilance/Drug Safety (521) seminar during summer 2020. | ||
| RSCI 521 | 1 | Regulatory Science SeminarTopic: “Dietary Supplements: Regulatory and Health Dynamics” | August 6 (pre-work required) | 9:00am-5:00pm |
| RSCI 532 | 3 | Early Stage Drug Development | May 16, 23, June 13, 27, July 25 | 9:00am-5:00pm |
| RSCI 590 | 1-3 | Directed Research [hybrid] | 4 meetings during the semester, 2 in-person [minimum] |