Spring 2025 Schedule -
MS in Global Clinical and Pharmacovigilance Regulations (GCPR) (Dec 19, 2024 updated)
PDF Copy of GCPR Schedule
The MS in Global Clinical and Pharmacovigilance Regulations (GCPR) is open to students with a PharmD, MD or DVM. Individuals with master's degrees that include extensive and advanced clinical experience may also be considered.
We recommend starting the MS in GCPR by taking Drug Development (5459/P381), Good Clinical Practices (5536/P383) and Clinical Trial Management (5537/P388).
After those foundation courses, we suggest registering for either Clinical Drug Safety and Pharmacovigilance (5538) or Post Marketing Safety Surveillance (5571), but you may also take Pharmacoepidemiology (5573) or another required course.
Remaining courses may then be taken in any order.
If you have not been formally accepted into the MS in GCPR, please include copy of your resume with your registration form.
You are expected to take proctored exams on the dates listed in the Schedule of Classes. Make sure you are available on the designated exam date. There is a first time fee of $25 charged to any student who cannot take the exam on the designated date and requests a makeup test; subsequently semesters, the fee increases to $50 per exam, and then $100. For more information on proctoring and these fees, click here.
Required Courses for MS in GCPR
- Drug Development (5459/P381) - offered Spring 2025
- Good Clinical Practices (5536/P383) - offered Spring 2025
- Clinical Trial Management (5537/P388) - offered Spring 2025
- Clinical Drug Safety & Pharmacovigilance (5538) OR Post-Marketing Safety Surveillance (5571)
- Good Pharmacovigilance Operations (5508) - Offered Spring 2025
- Pharmacoepidemiology (5573) - Offered Spring 2025
- Risk Management and Safety Signaling in Healthcare Products (5578) - Offered Spring 2025
- Regulatory and Legal Basis of Pharmacovigilance (5579)
Elective Courses for MS in GCPR
- Global Clinical Drug Development (5539)
- Fundamentals of Pharmacology & Pharmacokinetics (5401) (not open to TUSP PharmD students)
- Bioethics for Pharmaceutical Professionals (5612) - offered Spring 2025 (Not open to TUSP PharmD students)
- Adverse Drug Reactions (P312)
- Clinical Data Management (5618)
- Clinical Trial Project Management (5547)
Global Clinical and Pharmacovigilance Regulations - Spring 2025 SCHEDULE
All GCPR courses will be offered online using Zoom as the teaching platform. Zoom is free to all registered Temple students.
Required hardware
Online courses are interactive, so you must have a webcam and microphone to participate. Many laptops already have built-in webcams and speakers. If you use a device that does not, you must purchase them.If you're a new student, watch our online course tutorial. A password is given at the end which must be included on your registration form.
After watching the tutorial, schedule a short Zoom meeting with Jessie Chen (jessie.chen@temple.edu) or David Brickett ([click-for-email]) to review how Zoom works, so you'll be ready for your first RAQA class meeting.
Proctorio is an online proctoring service that enables you to take exams at almost any location. There is no extra charge for using Proctorio.
You must have a laptop or computer for Proctorio exams. (Chrome notebooks, iPad, cell phones and other devices will not work). You must also have administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that will now allow software downloads.) Please check this before registering.
Note: Due to visa requirements, international students must attend courses on-campus, which includes taking online courses in the Ft Washington computer lab.
REQUIRED COURSES for the MS in GCPR
5459. Drug Development (990) crn: 42713 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 6 (Proctorio)
Faculty: C. Ciliberto
Suggested text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have completed RAQA 459 or TUSP PharmD students who have taken P381.5459. Drug Development (991) crn: 28687 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
In addition, students will be required to choose one of the following texts and write a book review: 1. Ten Drugs, Hager, ISBN: 13-97: 1419735226;
2. For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug; Vardi; ISBN-13: 978-0393540956: 3. Making Medicine: Surprising Stories from the History of Drug Discovery, hardcover, July 2022; Veronese; ISBN-13: 978-1633887534.
Not open to students who have completed RAQA 459 or TUSP PharmD students who have taken P381.WEEKEND COURSE
5459. Drug Development (992) crn: 51026 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring..
10:00 am – 1:00 pm Saturdays: Jan 18, 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5. Meets 12 times plus final exam. Make-ups, if needed, Apr 12 and 19 (Passover).
Proctored exam: Mar 1 (Proctorio)
Faculty: D. Walsh
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272), and 2) The Great Influenza, John M. Barry, Penguin 2004-5, (ISBN 0-14-303649-1)
Not open to students who have completed RAQA 459 or TUSP PharmD students who have taken P381.5508. Good Pharmacovigilance Operations (990) crn: 53066 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 16 (Passover), 23. Meets 12 times plus final exam. No class April 9. Make-up, if needed, Apr 30 and May 7.
Proctored exam: Apr 23 (Proctorio)
Faculty: L. Thomas
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.5536. Good Clinical Practices (990) crn: 51052 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 10 (Proctorio)
Faculty: J. Hayes
No required text.
Optional texts (Do not purchase until after the first class meeting): 1) The Autumn Ghost: How the Battle Against a Polio Epidemic Revolutionized Modern Medical Care; H. Wunsch; ISBN-13: 978-1771649452; 2) The Breakthrough: Immunotherapy and the Race to Cure Cancer; C. Graeber; ISBN-13: 978-1455568505; 3) Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide; C.K. Warsh; ISBN-13: 978-0197632543.
Not open to students who have completed RAQA 536 or TUSP PharmD students who have taken P383.5537. Clinical Trial Management (990) crn: 20667 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Good Clinical Practices (5536). Students with clinical experience may ask to take the course but must include their resume with registration.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 98, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537 or TUSP PharmD students who have taken P388.5538. Clinical Drug Safety and Pharmacovigilance 990) (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Good Clinical Practices (5536) or appropriate experience in industry GCPs.5:30 pm - 8:30 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover), 21. Meets 12 times plus final exam. Make-up, if needed, Apr 28 and May 5.
Proctored final exam: April 21
Faculty: C. Baldridge
Required text: Cobert’s Manual of Drug Safety and Pharmacovigilance, 4th Edition only, Feb 2025, Cobert, Gregory, Thomas, Baldridge. https://www.worldscientific.com/worldscibooks/10.1142/13970#t=aboutBook
5573. Pharmacoepidemiology (990) crn: 51062 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:30 pm Mondays: Jan 27, Feb 3, 10, 17 Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7. Meets 10 times plus final exam. Make-ups, if needed, Apr 14 (Passover) and 21.
Proctored exam: Apr 7 (Proctorio)
Faculty: N. Cossrow
No required text.5578. Risk Management and Safety Signaling of Healthcare Products (990) crn: 53070 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: either RAQA 5538 or RAQA 5571.
7:00 pm - 10:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 24 and May 1.
Proctored exam: Apr 17 (Proctorio)
Faculty: J. Robinson
No required text.ELECTIVE COURSES in GCPR
Special note: Elective courses are not open to TUSP PharmD students pursuing the GCPR MS.5612. Bioethics for Pharmaceutical Professionals (990) crn: 28699 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 6 (Proctorio)
Faculty: D. Walsh
Required text: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, Emanuel, Crouch, Arras, Moreno and Grady, Johns Hopkins University Press, 2003.
Not open to students who completed RAQA 512 or TUSP students pursuing the GCPR MS.Expectations for Online Students
Registration Form for Online Students
To register for On-Campus courses use:
REGISTRATION FORM for On-Campus Courses
Email your registration form to: QARAREG@temple.edu
OR, PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565
OR, MAIL YOUR REGISTRATION TO:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
Is this your first registration in the non-thesis MS program? If so, you must complete and forward a Residency Form. Call the RAQA Office for instructions (267.468.8560).
Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver