Summer 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 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 Summer 2024
- Good Clinical Practices (5536/P383) - offered Summer 2024
- Clinical Trial Management (5537/P388) - offered Summer 2024 (RAQA and PharmD)
- Clinical Drug Safety & Pharmacovigilance (5538) OR Post-Marketing Safety Surveillance (5571) (5538 offered Summer)
- Good Pharmacovigilance Operations (5508) - Offered Spring 2024
- Pharmacoepidemiology (5573) - Offered Spring 2024
- Risk Management and Safety Signaling in Healthcare Products (5578) - Offered Spring 2024
- Regulatory and Legal Basis of Pharmacovigilance (5579) - Offered Spring 2024
Elective Courses for MS in GCPR
- Global Clinical Drug Development (5539) - offered Spring 2024
- Fundamentals of Pharmacology & Pharmacokinetics (5401) or an approved course in Clinical Pharmacology (special permission required) - offered Summer 2024
- Bioethics for Pharmaceutical Professionals (5612) - offered Spring 2024
- Adverse Drug Reactions (P312)
- Statistics for Clinical Trials (5497) - offered Fall 2023
- Clinical Data Management (5618)
- Clinical Trial Project Management (5547) - offered Summer 2024
Global Clinical and Pharmacovigilance Regulations - Summer 2024 SCHEDULE
All Summer 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.
WEEKEND COURSE
5459. Drug Development (990) crn: 2539 (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: May 18, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3, 10. Meets 12 times plus final exam. No class May 25 (Memorial Day weekend). Make-ups, if needed, Aug 17 and 24.
Proctored exam: July 13 (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 459.5459. Drug Development (991) crn: 6040 (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: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: July 10 (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
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 459.5536. Good Clinical Practices (990) crn: 3423 (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: May 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. No class May 27 (Memorial Day). Make-ups, if needed, Aug 19 and 26.
Proctored exam: July 98(RPNow)
Faculty: J. Hayes
Required texts (Students will be required to choose one): 1) The Nazi Doctors and the Nuremberg Code; Annas and Grodin; OR, 2) Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims, Vanderbes; OR, 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 536.5537. Clinical Trial Management (990) crn: 5872 (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 Tuesdays: 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: July 2 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (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 or P383) or appropriate experience in industry GCPs (send resume with registration form).
7:00 pm – 10:00 pm Thursdays: May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15, 22. Meets 12 times plus final exam. No class July 4. Make-ups, if needed, Aug 29 and Sept 5.
Proctored exam: Aug 22 (RPNow)
Faculty: J. Robinson
No required text.ELECTIVE COURSES in GCPR
5401. Fundamentals of Pharmacology and Pharmacokinetics (990) crn: 13329 (ONLINE) Expectations for Online Students Registration Form for Online Students
Prerequisite: science background. Special permission required to take this course as an elective in the MS in GCPR program. Contact the RAQA Office before registering.
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.
6:00pm – 9:00 pm Wednesdays: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: July 10 (RPNow)
Faculty: C. Cronenberger and K. Sweeney
Suggested texts: 1. Applied Biopharmaceutics and Pharmacokinetics, Shargel, Yu, Wu-Pon (ISBN-13: 978-0071603935; ISBN-10: 007160393X), 6th edition.
2. Basic Pharmacokinetics and Pharmacodynamics, an Integrated Textbook and Computer Simulations, Rosenbaum (ISBN-13: 978-0470569061; ISBN-10: 0470569069), 1st edition.
Not open to students who have completed RAQA 400 or 405.5547. Project Management for Clinical Trials (990) crn: 11572 (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: May 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. No class May 27 (Memorial Day). Make-ups, if needed, Aug 19 and 26.
Proctored exam: July 1 (RPNow)
Faculty: J. Sheldon
Recommended text: Project Management for the Pharmaceutical Industry, June 2011, revised reprint. Available online thought the Temple University Charles Library.
Not open to students who have taken 5615: Project Management for Pharmaceutical ProfessionalsExpectations 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