Spring 2024 Schedule
for the MS in Global Clinical and Pharmacovigilance Regulations (GCPR)
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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 Spring
- Good Clinical Practices (5536/P383) - offered Spring
- Clinical Trial Management (5537/P388) - offered Spring (RAQA and PharmD)
- Clinical Drug Safety and Pharmacovilance (5538) OR Post-Marketing Safety Surveillance (5571) (5571 offered Spring)
- Good Pharmacovigilance Operations (5508) - Offered Spring
- Pharmacoepidemiology (5573) - Offered Spring
- Risk Management and Safty Signaling in Healthcare Products (5578) - Offered Spring
- Regulatory and Legal Basis of Pharmacovigilance (5579) - Offered Spring
Elective Courses for MS in GCPR
- Global Clinical Drug Development (5539) - offered Spring
- Fundamentals of Pharmacology & Pharmaokinetics (5401) or an approved course in Clinical Pharmacology (special permission required)
- Bioethics for Pharmaceutical Professionals (5612) - offered Spring
- 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 - Spring 2024 SCHEDULE
All Spring 2024 RAQA courses will be offered online using Zoom as the teaching platform. 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 ([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.
WEEKEND COURSE
5459. Drug Development (990) crn: 42713 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 20, 27, Feb 3, 10, 17, 24, Mar 2, 9, 16, 23, Apr 6, 13. Meets 12 times plus final exam. No class March 30. Make-ups, if needed, Apr 20 and 27.
Proctored exam: Mar 2 (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: 28687 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (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 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 Barry, OR
4) The Antidote: Inside the World of New Pharma, Barry Werth.
Not open to students who have completed RAQA 459 or P381.5459. Drug Development (992) crn: 51026 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: To be announced.
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
No open to students who have completed RAQA 459 or P381.5508. Good Pharmacovigilance Operations (990) crn: 53066 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 15, 22. Meets 12 times plus final exam. No class Apr 8. Make-ups, if needed, Apr 29 and May 6.
Proctored final exam: Apr 22 (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. Do not purchase until you attend the first class.5536. Good Clinical Practices (990) crn: 51052 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2. Meets 12 times plus final exam. Make-ups, if needed, Apr 9 and 16.
Proctored exam: Feb 27 (RPNow)
Faculty: D. Weiss
No required text.
Not open to students who have completed RAQA 536 or P383.5536. Good Clinical Practices (991) crn: 42932 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: J. Hayes
Required text: Students will be required to choose one of the following texts and write a book review: 1) The Nazi Doctors and the Nuremberg Code; Annas and Grodin, 2) Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims, Vanderbes and 3) Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases; P.A Offit, MD
Not open to students who have completed RAQA 536 or P383.5537. Clinical Trial Management (990) crn: 20667 (ONLINE) Expectations for Online Students Registration Form for Online Students
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 Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537 or P388.SIX WEEK SCHEDULE TWICE A WEEK
5571. Post Marketing Safety Surveillance (990) crn: 42724 (ONLINE) Expectations for Online Students Registration Form for Online Students
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 and Wednesdays: Jan 17, 22, 24, 29, 31, Feb 5, 7, 12, 14, 19 (Presidents' Day), 21, 26. Meets 12 times plus final exam. Make-ups, if needed, Feb 28 and Mar 4.
Proctored exam: Feb 12 (RPNow)
Faculty: V. Patadia
Required text: Mann’s Pharmacovigilance, Author: Edited by Elizabeth B. Andrews, Nicholas Moore ISBN: 978-0-470-67104-7, Publisher: Wiley Blackwell Edition: 3rd Edition
Not open to students who have taken RAQA 571.5573. Pharmacoepidemiology (990) crn: 51062 (ONLINE) Expectations for Online Students Registration Form for Online Students
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 – 9:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1. Meets 10 times plus final exam. Make-ups, if needed, Apr 8 and 15.
Proctored exam: Apr 1 (RPNow)
Faculty: N. Cossrow
No required text.
Not open to students who have taken RAQA 570.5578. Risk Management and Safety Signaling of Healthcare Products (990) crn: 53070 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: at least one course in Pharmacovigilance (5508, 5538, 5571, 5573, or 5579, or special permission of RAQA Office).
7:00 pm – 10:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 21, 28, Apr 4, 11. Meets 12 times plus final exam. No class Mar 14. Make-ups, if needed, Apr 18 and 25.
Proctored exam: Feb 29 (RPNow)
Faculty: J. Robinson
No required text.5579. Regulatory and Legal Basis of Pharmacovigilance (990) crn: 53071 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Post Marketing Safety Surveillance (5571) OR Clinical Drug Safety and Pharmacovigilance (5538) or special permission (include resume).
6:00 pm – 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Apr 9 (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
5539. Global Clinical Drug Development (990) crn: 53068 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: K. Weiss
No required text.
Not open to students who have completed RAQA 539.5612. Bioethics for Pharmaceutical Professionals (990) crn: 28699 (ONLINE) Expectations for Online Students Registration Form for Online Students
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: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 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.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