MS in Global Clinical and Pharmacovigilance Regulations - Schedule of Classes (RAQA)

Fall 2023 Schedule
for the MS in Global Clinical and Pharmacovigilance Regulations (GCPR)

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 clinincal 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) first.

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
Good Clinical Practices (5536/P383) - offered Fall
Clinical Trial Management (5537/P388) - offered Fall (RAQA) or Spring (PharmD)
Clinical Drug Safety and Pharmacovilance (5538) OR Post-Marketing Safety Surveillance (5571)
Good Pharmacovigilance Operations (5508) - Offered Fall
Pharmacoepidemiology (5573)
Risk Management and Safty Signaling in Healthcare Products (5578)
Regulatory and Legal Basis of Pharmacovigilance (5579)

Elective Courses for MS in GCPR

Global Clinical Drug Development (5539)
Fundamentals of Pharmacology & Pharmaokinetics (5401) or an approved course in Clinical Pharmacology (special permission required)
Bioethics for Pharmaceutical Professionals (5612) - offered Fall 2023
Adverse Drug Reactions (P312)
Statistics for Clinical Trials (5497) - offered Fall 2023
Clinical Data Management (5618)
Clinical Trial Project Management (5547)

Global Clinical and Pharmacovigilance Regulations - FALL 2023 SCHEDULE PDF of GCPR Schedule

Almost all Fall 2023 RAQA courses will be offered online using Zoom as the teaching platform. (There is one section of Drug Development offered on-campus at Fort Washington this fall.)  Temple provides Zoom for 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 (dbrick@temple.edu) or Mike Doukas (mdoukas@temple.edu) 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.

REQUIRED COURSES – GCPR
DAYTIME ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (Fort Washington) (101) crn: 49409 Registration Form
2:00 pm - 5:30 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16. Meets 10 times plus final exam. Make-ups, if needed, Nov 30 and Dec 7.
In-class, proctored exam: Oct 12
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) 2) The Drug Hunters: The Improbable Quest to Discover New Medicines,
Not open to students who have 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 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
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 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 Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 27, Dec 4. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 11and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
In addition, students will be required to choose one of the following three 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 OR
3) The Great Influenza: The Story of the Deadliest Pandemic in History Paperback – Oct 2005, John M. Barry
Not open to students who have completed RAQA 459 or P381.

5459. Drug Development (992) crn: 28608 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use 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 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
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 OR
3) The Great Influenza: The Story of the Deadliest Pandemic in History Paperback – Oct 2005, John M. Barry
Not open to students who have completed RAQA 459 or P381.

OPEN ONLY TO STUDENTS PURSUING THE MS in GCPR or the Global Pharmacovigilance Certificate
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.
7:00 pm – 10:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-up, if needed, Dec 21.
Proctored final exam: Dec 14 (RPNow)
Faculty: J. Robinson
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833. Do not purchase until you attend the first class.

5536. Good Clinical Practices (990) crn: 9358 (ONLINE) Expectations of Online Students Registration Form for Online Courses  CLOSED. WAIT LIST ONLY.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. Make-ups, if needed, Dec 5 and 12.
Proctored exam: Oct 24 (RPNow)
Faculty: D. Weiss
No required text.
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 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537 or P388.

ELECTIVE COURSES in GCPR

5497. Statistics for Clinical Trials (990) crn: 54366 (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.
No prior knowledge of statistics required. Drug Development (5459) is helpful but not required.
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
Faculty: K. Weiss
No required text.
Not open to students who have completed RAQA 497.

WEEKEND COURSE
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.
10:00 am - 1:00 pm Saturdays: Sept 16, 23, 30, Oct 7 (Columbus Day weekend), 14, 21, 28, Nov 4, 11 (Veterans Day), 18, Dec 2, 9. Meets 12 times plus final exam. No class Nov 25. Make-up, if needed, Dec 16.
Proctored exam: Oct 28 (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.

Registration Form for Online Courses

To register for On-Campus courses use:
REGISTRATION FORM for On-Campus Courses

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 fax a RESIDENCY FORM

Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver

School of Pharmacy

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