Fall 2024 Schedule
for the MS in Global Clinical and Pharmacovigilance Regulations (GCPR)
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PDF Copy of GCPR Schedule
The MS in Global Clinical and Pharmacovigilance Regulations (GCPR) is open to students with a PharmD or MD. 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).
Once you've completed 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 Fall 2024
- Good Clinical Practices (5536/P383) - offered Fall 2024
- Clinical Trial Management (5537/P388) - offered Fall 2024 (RAQA) (P388 will be offered Spring 2025 for Temple U PharmD students)
- Clinical Drug Safety & Pharmacovigilance (5538) OR Post-Marketing Safety Surveillance (5571) (5538 offered this Fall)
- Good Pharmacovigilance Operations (5508) - Offered Fall 2024
- Pharmacoepidemiology (5573) - To be offered Spring 2025
- Risk Management and Safety Signaling in Healthcare Products (5578) - To be offered Spring 2025
- Regulatory and Legal Basis of Pharmacovigilance (5579) - Offered Fall 2024
Elective Courses for MS in GCPR
- Global Clinical Drug Development (5539) - offered Spring 2024
- Fundamentals of Pharmacology & Pharmacokinetics (5401) offered Summer 2024 (not open to TUSP PharmD students
- Bioethics for Pharmaceutical Professionals (5612) - offered Fall 2024 (Not open to TUSP PharmD students)
- Adverse Drug Reactions (P312)
- Clinical Data Management (5618)
- Clinical Trial Project Management (5547) - offered Summer 2024
Global Clinical and Pharmacovigilance Regulations - Fall 2024 SCHEDULE
All Fall 2024 GCPR courses will be offered online using Zoom as the teaching platform. Zoom is free to all registered Temple students.
Required hardware
Our 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 will be required to 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 David Brickett ([click-for-email]) or Mike Doukas ([click-for-email]) to review how Zoom works, so you'll be ready for your first RAQA class meeting.
RPNow is an online proctoring service that enables you to take exams at almost any location. RPNow charges $15.00 per exam, which you must pay with a credit card at the start of each exam. (You must also pay that fee if you take in RPNow exam in a University computer lab.) If a course uses RPNow, all students in the class must use that service.
You must have a laptop or computer for RPNow 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
Students pursuing the MS in Global Clinical and Pharmacovigilance Regulations should start the program by taking Drug Development, GCPs, and Clinical Trial Management first. Then they should take 5538 OR 5571 or 5573. After that, they may take courses in any order.
AFTERNOON ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (101) crn: 49409 (ON-CAMPUS COURSE) Expectations of Graduate Students Registration Form for On-Campus Courses
2:00 pm – 5:30 pm Wednesdays: Sept 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20. Meets 10 times plus final exam. Makeup, if needed, Dec 4 and 11.
In-class, proctored exam: Oct 16.
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISB-101: 1118907272), and 2) The Drug Hunters: the Improbable Quest to Discover New Medicines, Kirsch, 2017. Not open to students who completed RAQA 459 or P381.5459. Drug Development (990) crn: 17910 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: C. Ciliberto
Required 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 P381.5459. Drug Development (991) crn: 7407 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third 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) The Poison Squad: One Chemist's Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, Paperback – Illustrated, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair
3) The Great Influenza: The Story of the Deadliest Pandemic in History, Paperback – Oct 2005, John M. Barry
4) The Antidote: Inside the World of New Pharma, Barry Werth.
Not open to students who have completed RAQA 45 or P381.WEEKEND COURSE
5459. Drug Development (992) crn: 28608 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
8:30 am – 2:00 pm Saturdays: Sept 14, 28, Oct 12 (Columbus Day weekend), 26, Nov 9, 23, Dec 7. Meets 7 times plus final exam. Make-up, if needed, Dec 14.
Proctored exam: Oct 26 (RPNow)
Faculty: P. Smith
Required text: Drugs: From Discovery to Approval, third 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: 9358 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, Dec 3. Meets 12 times plus final exam. No class Nov 26. Make-ups, if needed, Dec 10 and 17.
Proctored exam: Oct 22 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 536 or P383.5508. Good Pharmacovigilance Operations (990) crn: 51972 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Mondays: Sept 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans' Day), 18, 25, Dec 2, 9. Meets 12 times plus final exam. Make-up, if needed, Dec 16.
Proctored exam: Dec 9 (RPNow)
Faculty: L. Thomas
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.WEEKEND COURSE
5536. Good Clinical Practices (991) crn: 56678 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
10:00 am – 1:00 pm Saturdays: Sept 7, 14, 21, 28, Oct 5, 12 (Yom Kippur), 19, 26, Nov 2, 9, 16, 23. Meets 12 times plus final exam. Make-ups, if needed, Dec 7 and 14.
Proctored exam: Oct 19 (RPNow)
Faculty: D. Walsh
Required texts: All references and readings are available online.
Not open to students who have completed RAQA 536 or P383.5537. Clinical Trial Management (990) crn: 49401 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
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: Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-up, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
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: 56672 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Good Clinical Practices (5536 or P383) or appropriate experience in industry GCPs (send resume with registration form).
Note: GCPR students may take 5538 or 5571 but not both.
7:00 pm – 10:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: J. Robinson
No required text.5579. Regulatory and Legal Basis of Pharmacovigilance (990) crn: 56674 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Clinical Drug Safety and Pharmacovigilance (5538) or Post Marketing Safety Surveillance (5571) or permission of RAQA Office (forward resume).
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4, 11. Meets 12 times plus final exam. No class Nov 27. Make-up, if needed, Dec 18.
Proctored exam: Dec 11 (RPNow)
Faculty: K. Ward
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.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: 42739 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
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