Summer 2025 Schedule -
MS in Global Clinical and Pharmacovigilance Regulations (GCPR) (Updated April 7, 2025)

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 the fee increases to $50 per exam, then $100, and then $150. For more information on proctoring and these fees, click here.

Required Courses for MS in GCPR

• Drug Development (5459/P381) - Summer 2025
• Good Clinical Practices (5536/P383) - Summer 2025
• Clinical Trial Management (5537/P388) - Summer 2025
• Clinical Drug Safety & Pharmacovigilance (5538)  - Summer 2025  OR Post-Marketing Safety Surveillance (5571)  
• Good Pharmacovigilance Operations (5508) - Fall 2025
• Pharmacoepidemiology (5573)  
• Risk Management and Safety Signaling in Healthcare Products (5578) - Offered Spring 2025
• Regulatory and Legal Basis of Pharmacovigilance (5579)  Fall 2025

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) - Summer 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 - Summer 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 charge for Proctorio. 

You must have a laptop or computer for Proctorio exams. (Chrome notebooks, iPad, cell phones and other devices will not work). You also need administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that do not allow 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: 2539  (ONLINE)  Proctorio online proctoring. Expectations of Online Students  Registration Form for Online Courses
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 and 20.
Proctored exam:  June 25 (Proctorio)
Faculty:  C. Ciliberto
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459 or P381.

WEEKEND COURSE
5459. Drug Development (991) crn: 6040 (ONLINE)  Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
9:00 am - 12:00 pm Sundays: May 18, June 1, 8, 15, 22, 29, July 13, 20 (recording), 27, Aug 3, 10, 17. Meets 12 times plus final exam.  No classes on May 25 and July 6. Make-up, if needed, Aug 24.
Proctored exam:  July 13 (Proctorio)
Faculty: M. Rubio
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459 or P381.

5536. Good Clinical Practices (990) crn: 3423 (ONLINE)  Proctorio online proctoring. Expectations of Online Students  Registration Form for Online Courses
6:00 pm - 9:00 pm Mondays: May 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4, 11.  Meets 12 times plus final exam. No class May 26 (Memorial Day).  Make-ups, if needed, Aug 18 and 25.
Proctored exam:  July 7 (Proctorio)
Faculty:  J. Hayes
Optional texts (Students are required to choose one of the following after the first class): 
1) Polio: An American Story; D.M. Oshinsky.
2) Do You Believe in Magic? (The Sense and Nonsense of Alternative Medicine (Vitamins, Supplements, and All Things Natural: A Look Behind the Curtain), P. Offit;
3) The Chimp & the River: How AIDS Emerged from an African Forest, D. Quamman;
4) The Speckled Monster: A Historical Tale of Battling Smallpox, J.L Carrell
Not open to students who have completed RAQA 536 or P383.

5537. Clinical Trial Management (990) crn: 5872 (ONLINE) Proctorio online proctoring. Expectations of Online Students  Registration Form for Online Courses
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 Tuesdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 and 19.
Proctored exam:  July 1 (Proctorio)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537 or P388.

5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (ONLINE) Proctorio online proctoring. Expectations of Online Students  Registration Form for Online Courses
Suggested prerequisite: Good Clinical Practices (5536).
7:00 pm - 10:15 pm Thursdays: May 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14, 21.  Meets 11 times plus final exam.  No class July 3. Make-up, if needed, Aug 28.
Proctored exam:  Aug 21 (Proctorio).
Faculty:  J. Robinson
Recommended text: Cobert’s Manual of Drug Safety and Pharmacovigilance, 4^th edition only, Feb 2025, Cobert, Gregory, Thomas, Baldridge: https://www.worldscientific.com/worldscibooks/10.1142/13970#t=aboutBook

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: 14473  (ONLINE)  Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
10:00 am - 1:30 pm Saturdays: May 17, 31, June 7, 14, 21, 28, July 12, 19, 26, Aug 2, 9, 16.  Meets 10 times plus final exam. No class May 24 and July 5.  
Proctored exam:  Aug 16 (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.

Expectations for Online Students

Registration Form for Online Students

Residency Form

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 RAQA GCPR graduate program? If so, you must fax a Non-Matriculated Graduate Student Waiver