Course Schedules

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 courses should be considered “hybrid” courses, even for students attending class onsite for listed course dates. Additional interactions with faculty will typically take place via distance modules before and after onsite dates. Details about distance modules will be outlined in individual course syllabi.

Spring 2021

MPTX 511 3 Introduction to Medical Product Regulation [hybrid] 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 [hybrid] 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 [hybrid] January 9, February 13, March 7, April 10, 25 (HSC, CHP) 9:00am-5:00pm
RSCI 521 1 Seminar in Regulatory Science – Journal Club [online] Every Wednesday, Jan. 13-Apr. 28  (HSC, CHP) 12:00pm-1:00pm
RSCI 521 1 Seminar in Regulatory Science – CTSI Symposium (Topic TBD) [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 [hybrid] 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 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
MPTX 526 3 Chemistry Manufacturing and Controls

CANCELED

August 30, September 12, October 10, 25, November 8 9:00am-5:00pm
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, June 15, July 13, July 27 (HSC, CHP) 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