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 that you check this page before scheduling other activities. Click here to view the main Schedule of Classes and note important add/drop dates.
Schedules are tentative.
All classes will be held online for the summer term. Additional interactions with faculty take place via Zoom before and after session dates. Details about distance modules will be outlined in individual course syllabi.
Summer 2021
| 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 Seminar
Topic: “Pharmacovigilance” This course is not recommended for students who attended the Pharmacovigilance/Drug Safety (521) seminar during summer 2020.
|
May 29
|
9:00am-4:00pm |
| RSCI 521 | 1 | Regulatory Science Seminar
Topic: “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] |
Spring 2021
| MPTX 511 | 3 | Introduction to Medical Product Regulation [online] | January 10, 31, February 27, March 21, April 24 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products [online] | January 16, February 6, 28, March 20, April 10 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 519 | 3 | Global Regulation of Medical Products [online] | January 24, February 13, March 14, April 9, April 18 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 522 | 3 | Introduction to Clinical Trial Design and Statistics [online] | January 9, 30, February 20, March 6, April 17 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 509 | 3 | Quality Assurance for Medical Devices and Combination Products [online] | January 9, February 13, March 7, April 10, 25 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 (49121) | 1 | Seminar in Regulatory Science – Journal Club [online] | Every Wednesday, Jan. 13-Apr. 28 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 521 (49122) | 1 | Seminar in Regulatory Science – CTSI/APEC Symposium “International Standard for Conducting Device Trials” [online] | April 9 (HSC, PSC) | 9:00am-5:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology [online] | January 9, 30, February 20, March 13, April 11 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 531 | 4 | Drug Discovery [online] | January 10, 31, February 21, March 14, 28, April 18 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 541 | 3 | Medical Product Development, Reimbursement, and Marketing [online] | January 24, February 7, 28, March 28, April 11 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 590 | 1 | Directed Research [hybrid] | 4 meetings during the semester, 2 in person [minimum] (HSC, CHP) | 9:00am-5:00pm |
| RSCI 601 | 4 | Biomedical Commerce [online] | January 10, 23, February 21, March 28, April 24 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 603 | 3 | Managing Complex Projects (DRSc and RMGT only) [online] | January 17, February 6, March 6, 27, 31 (midterm), April 9, 17 (HSC, CHP) | 9:00am-3:00pm |
Fall 2020
| MPTX 511 | 3 | Introduction to Medical Product Regulation
Online |
August 30, September 13, October 11, November 15, 22 | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices and Diagnostics
Online |
August 22, September 19, October 3, 17, November 7 | 9:00am-5:00pm |
| MPTX 516 | 3 | Medical Products and the Law
Online |
August 30, September 20, October 11, November 15, 22 | 9:00am-5:00pm |
| MPTX 517
|
4
|
Structure and Management of Clinical Trials
Online |
August 29, September 12, 26, October 24, November 14 | 9:00am-5:00pm |
| MPTX 518 | 3 | Writing Regulatory Drug Submissions
Online |
August 22, September 19, October 3, 17, November 21 | 9:00am-5:00pm |
CANCELED |
||||
| RSCI 506 | 3 | Auditing Principles
Online |
October 4, 11, 25, November 7, 15 | 9:00am-5:00pm |
| RSCI 507 | 2 | Quality Systems and Statistical Process Control
Online |
October 10, 17, November 7, November 8 | 9:00am-5:00pm |
| RSCI 508 | 3 | Quality Assurance for Drugs and Biologics
Online |
August 23, September 20, October 4, 18, November 8 | 9:00am-5:00pm |
| RSCI 520 | 2 | Risk Management
Online |
August 16, 23, September 19, 26 | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Auditing Principles
Online |
Students must attend the first class of RSCI 506 and attend one of the following:
GLP (October 4, October 11) GMP (October 4, October 25) GCP (October 4, November 7) |
9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Symposium “Diversity in Clinical Trials in the Time of COVID-19 “ Online |
October 16, 2020 | 9:00am-3:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Writing Seminar
Online |
August 22
October 3 |
9:45am-5:00pm
1:00pm-5:00pm |
| RSCI 533 | 3 | Safety Evaluation During Drug Development
Online |
August 23, September 13, October 17, 18, November 15 | 9:00am-5:00pm |
| RSCI 590 | 3 | TRAQS Project | ||
| RSCI 605 | 3 | Managing Organizations and Human Resources – DRSc students only
Online |
August 22, September 20, October 14 (6pm-7:10pm), 24, 25, November 21 | 9:00am-5:00pm |
Summer 2020
| MPTX 511 | 3 | Introduction to Medical Product Regulation | May 17, May 31, June 7, June 27, July 26 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | May 16, May 31, June 27, July 18, July 26 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices
Possibly two days with APEC |
May 16, May 30, June 13, June 28, July 18 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 514 | 3 | Regulation of Food and Dietary Supplements | May 16, June 13, June 20, July 18, July 25 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 515 | 3 | Quality Systems and Standards | May 17, May 31, June 14, June 27, July 19 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | July 11, July 12, July 25, Aug 1, Aug 2 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Regulatory Science Seminar
Understanding Pharmacovigilance Operations: An Insider’s View |
July 24 & 25
(final two days of RSCI 527) |
9:00am-5:00pm |
| RSCI 527 | 3 | Medical Product Safety | June 6, June 7, June 28, July 19, July 24, 25 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 532 | 3 | Early Stage Drug Development |
May 17, June 14, June 28, July 12, July 19 (HSC, CHP) |
9:00am-5:00pm |
| RSCI 607 | 4 | Theory, Methods, and Practice of Medical Products Research – DRSc only |
May 6, 13, 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22 (Zoom) |
6:00pm-7:45pm |
Spring 2020
| MPTX 511 | 3 | Introduction to Medical Product Regulation | January 12, 26, February 16, March 7, April 5 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | January 18, February 9, March 7, March 29, April 11 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | January 11, February 8, 23, March 7, April 5 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 519 | 3 | Global Regulation of Medical Products | January 19, February 1, 29, April 24, April 25 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 509 | 3 | Quality Assurance for Medical Devices and Combination Products | January 11, February 22, March 8, April 4, April 18 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal Club | Wednesdays, January 15- April 29 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Bootcamp “Quality by Design” | TBD (HSC, PSC) | 9:00am-5:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology | March 7, 21, 29, April 5, 26 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 531 | 4 | Drug Discovery | January 12, February 9, 23, March 8, 22, April 26 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 601 | 4 | Biomedical Commerce | January 12, February 1, 22, March 1, April 4, 26 [optional] (HSC, CHP) | 9:00am-5:00pm |
| RSCI 603 | 3 | Managing Complex Projects | January 18, 19, February 29, March 28, April 18 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 608 | 4 | Regulatory Strategy in Europe & the Americas (DRSc only) | March 13 – March 22 |
Fall 2019
| MPTX 511 | 3 | Introduction to Medical Product Regulation | August 18, September 7, September 22, October 6, November 3 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices and Diagnostics | August 17, September 15, October 12, November 2, November 17 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 516 | 3 | Medical Products and the Law | August 25, September 15, September 29, October 27, November 10 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 518 | 3 | Writing Regulatory Drug Submissions | August 25, September 7, September 14, September 22, October 5 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 522 | 3 | Introduction to Clinical Trial Design and Statistics | August 24, September 21, October 19, November 3, November 17 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 526 | 3 | Chemistry Manufacturing and Controls | August 24, September 21, October 13, October 26, November 23 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 506 | 3 | Auditing Principles | October 12, October 20, October 27, November 2, November 16 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 507 | 2 | Quality Systems and Statistical Process Control | October 12, October 19, November 9, November 10 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 508 | 3 | Quality Assurance for Drugs and Biologics | August 18, September 14, October 13, November 3, November 16 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 520 | 2 | Risk Management | August 24, September 8, September 28, October 6 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Auditing Principles | Attend one of the following:
GLP (October 12, Ocotber 20) (HSC, CHP) GMP (October 12, October 27) (HSC, CHP) GCP (October 12, November 2) (HSC, CHP) |
9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Bootcamp “Legal Aspects of Clinical Trials” |
November 1 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal Club | Wednesdays, August 21 – December 4 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 590 | 3 | TRAQS Project | 9:00am-5:00pm | |
| RSCI 604 (Special Session, Dr. Richmond & Dr. Kuo) | 4 | WebEx dates TBD
October 13-26 (Asia trip) |
(HSC, CHP) | 9:00am-5:00pm |
| RSCI 606 | 3 | Regulation of Emerging Technologies and Biological Products
|
August 25, September 15, September 28, September 29, October 5 (HSC, CHP)
|
9:00am-5:00pm |
Summer 2019
| MPTX 511 | 3 | Introduction to Medical Product Regulation | May 12, June 2, June 9, June 22, July 14 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | May 11, June 1, June 22, June 30, July 13, July 21 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices
Class meets on campus 3 days only. Students have the option to attend APEC workshops April 30-May 2 or view the live stream. |
May 19, June 1, |
9:00am-5:00pm |
| MPTX 514 | 3 | Regulation of Food and Dietary Supplements | May 18, June 23, June 30, July 20, July 26 (Pharmavite Field Trip) (HSC, CHP) | 9:00am-5:00pm |
| MPTX 515 | 3 | Quality Systems and Standards | May 11, June 2, June 23, July 14, July 28 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | June 14, 15, 16, 17 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 602 | 2 | Science, Research, and Ethics | May 12, June 16, June 30, July 13 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Regulatory Science Bootcamp Seminar: Clinical Trials with Medical Devices
This is offered with the participation of the Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence training program. |
May 3 (PSC 112)
Attending on-site is optional. This is a distance course, starting May 11, concluding June 21. |
9:00am-4:00pm |
| RSCI 527 | 3 | Medical Product Safety |
May 18, May 19, June 8, June 9, June 29 (HSC, CHP) |
9:00am-5:00pm |
| RSCI 532 | 3 | Early Stage Drug Development |
May 12, May 19, June 9, June 29, July 7 (HSC, CHP) |
9:00am-5:00pm |
Spring 2019
| MPTX 511 | 3 | Introduction to Medical Product Regulation | January 4, 20, February 3, March 3, April 14 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | January 6, 19, February 2, February 24, March 16, April 13 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | January 12, 26, February 16, March 16, April 14 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 519 | 3 | Global Regulation of Medical Products | January 13, 27, February 17, March 17, April 7 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 509 | 3 | Quality Assurance for Medical Devices and Combination Products | January 12, February 9, March 9, 30, April 27 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal Club | Wednesdays, January 9- April 24 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Bootcamp: Real World Evidence and Patient-Centered Drug Development (Tentative) | March 15 (HSC, PSC) | 9:00am-5:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology | March 2, 23, April 6, 20, 27 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 531 | 4 | Drug Discovery | January 6, 27, February 17, March 10, 31, April 14 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 541 | 3 | Medical Product Development, Reimbursement, and Marketing | January 13, February 10, March 3, 24, April 7 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 601 | 4 | Biomedical Commerce | January 19, February 3, 23, March 17, April 13 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 603 | 3 | Managing Complex Projects (DRSc and MS RGMT only) |
January 5, 6, February 16, 17, March 23 (HSC, CHP) | 9:00am-5:00pm |
Fall 2018
| MPTX 511 | 3 | Introduction to Medical Product Regulation | August 24, September 9, September 23, October 21, November 18 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices and Diagnostics | August 19, September 29, October 13, November 4, November 10 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 516 | 3 | Medical Products and the Law | August 26, September 16, October 7, November 4, November 17 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | CANCELED | |
| MPTX 518 | 3 | Writing Regulatory Drug Submissions | August 19, September 9, September 23, September 30, October 6 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 526 | 3 | Chemistry Manufacturing and Controls | CANCELED | |
| RSCI 506 | 3 | Auditing Principles | October 14, October 21, November 4, November 17, December 1 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 507 | 2 | Quality Systems and Statistical Process Control | October 13, October 20, November 10, November 11 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 508 | 3 | Quality Assurance for Drugs and Biologics | August 25, September 15, October 6, October 20, November 10 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 520 | 2 | Risk Management | August 18, September 9, September 29, September 30 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Auditing Principles | Attend one of the following:
GLP (October 14, November 4) (HSC, CHP) GMP (October 14, October 21) (HSC, CHP) GCP (October 14, November 17) (HSC, CHP) |
9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Bootcamp “Pharmacovigilance and Safety Reporting” | October 12 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal Club | Wednesdays, August 22 – November 28 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 533 | 3 | Safety Evaluation During Drug Development | August 26, September 16, October 27, October 28, November 11 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 590 | 3 | TRAQS Project | (HSC, CHP) | 9:00am-5:00pm |
| RSCI 604 (Special Session, Dr. Richmond & Dr. Kuo) | 4 | September 16 (Introduction/Orientation)
October 13-20 (Class in China) November 18 (Group presentations) |
(HSC, CHP)
(HSC, CHP) |
9:00am-5:00pm |
| RSCI 605 | 3 | Managing Organizations and Human Resources – DRSc students only | August 26, September 15, September 27 (1/2 day), October 11 (1/2 day)
Cruise: Oct 26-29 November 17 (HSC, CHP) |
9:00am-5:00pm |
Summer 2018
| MPTX 511 | 3 | Introduction to Medical Product Regulation | May 12, May 20, June 17, July 8, July 29 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | May 13, June 2, June 10, June 24, July 14, July 21 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 513 | 3 | Regulation of Medical Devices | May 19, June 9, June 30, July 15, July 22 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 514 | 3 | Regulation of Food and Dietary Supplements | May 19, June 3, June 16, July 7, July 27 (Pharmavite) (HSC, CHP) | 9:00am-5:00pm |
| MPTX 515 | 3 | Quality Systems and Standards | May 12, June 2, June 23, July 14, July 28 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | July 20, 21, 22, 23 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 602 | 2 | Science, Research, and Ethics – Not confirmed | TBD | 9:00am-5:00pm |
| RSCI 527 | 3 | Medical Product Safety | May 14, June 3, June 16, June 24, July 8 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 532 | 3 | Early Stage Drug Development |
May 20, June 10, June 30, July 15, July 29 (HSC, CHP) |
9:00am-5:00pm |
| RSCI 607 | 4 | Theory, Methods, and Practice of Medical Products Research – DRSc only |
May 12 (10:00am), June 2, June 10, July 7, July 21 (HSC, CHP) |
9:00am-5:00pm |
Spring 2018
| MPTX 511 | 3 | Introduction to Medical Product Regulation | January 14, 26, February 4, March 4, April 15 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 512 | 3 | Regulation of Drugs and Biological Products | January 6, 20, February 4, March 17, 24, April 8 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 517 | 4 | Structure and Management of Clinical Trials | January 13, 27, February 2, 10, 24 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 519 | 3 | Global Regulation of Medical Products | January 7, 21, February 11, March 11, April 22 (HSC, CHP) | 9:00am-5:00pm |
| MPTX 522 | 3 | Clinical Trial Design | January 21, February 11, March 3, 18, April 8 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 509 | 3 | Quality Assurance for Medical Devices and Combination Products | January 6, 27, February 25, March 17, April 7 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – Journal Club | Wednesdays, January 10 – May 2 (HSC, CHP) | 12:00pm-1:00pm |
| RSCI 521 | 1 | Seminar in Regulatory Science – CTSI Bootcamp: “Clinical Design Elements” | March 8 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 525 | 3 | Introduction to Food and Drug Toxicology | January 14, February 3, 24, March 25, April 22 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 531 | 4 | Drug Discovery | January 13, 28, February 25, March 4, 25, April 29 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 601 | 4 | Biomedical Commerce | January 14, 28, February 4, March 10, April 29 (HSC, CHP) | 9:00am-5:00pm |
| RSCI 603 | 3 | Managing Complex Projects | January 7, February 11, March 3, 24, April 15 (HSC, CHP) | 9:00am-5:00pm |