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

SUMMER 2022 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 Global Clinical and Pharmacovigilance Regulations (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; in subsequent semesters, the fee increases to $35 per exam and then $50 per exam. For more information on proctoring and these fees, click here.

Required Courses for MS in GCPR

  • Drug Development (5459/P381) - offered Summer
  • Good Clinical Practices (5536/P383) - offered Summer
  • Clinical Trial Management (5537/P388) - offered Summer
  • Clinical Drug Safety and Pharmacovilance (5538) OR Post-Marketing Safety Surveillance (5571) 
  • Good Pharmacovigilance Operations (5508) 
  • Pharmacoepidemiology (5573) - offered Summer
  • Risk Management and Safty Signaling in Healthcare Products (5578) - offered Summer
  • Regulatory and Legal Basis of Pharmacovigilance (5579) - offered Fall 2022 (only offered in Fall)

Elective Courses for MS in GCPR

  • Global Clinical Drug Development (5539) 
  • Fundamentals of Pharmacology & Pharmaokinetics (5401) or an approved course in Clinical Pharmacology
  • Bioethics for Pharmaceutical Professions (5612) - offered Summer
  • Adverse Drug Reactions
  • Statistics for Clinical Trials (5497) 
 
Summer 2022 Schedule 

Global Clinical and Pharmacovigilance Regulations

Most Summer 2022 RAQA courses will be offered online using Zoom as the teaching platform. Temple provides Zoom for free to all registered Temple students.  Drug Development (5459) is also being offered on-campus at the Ft Washington site for students in the Philadelphia area.

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.

 

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

ON-CAMPUS COURSES at Fort Washington
5459.  Drug Development (111) crn:  12415 (FORT WASHINGTON) Registration for On-Campus Course

6:00 pm – 9:30 pm Thursdays:  May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21.  Meets 10 times plus final exam.  Make-ups, if needed, July 28 and Aug 4.
In-class, proctored exam:  June 16
Faculty:  P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272)
2) The Drug Hunters: The Improbable Quest to Discover New Medicines, Kirsch and Ogas, ISBN: 13:978-1628729863.
Not open to students who have completed RAQA 459.

5459.  Drug Development (990) crn: 2539  (ONLINE) Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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 Wednesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 10 and 17.
Proctored exam:  June 29 (RPNow)
Faculty:  J. Hayes
Required text: Drugs: From Discovery to Approval, Ng, 3rd end, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
In addition, student will be required to choose one of the three texts and write a book review.
1.) A Shot to Save the World: The Inside Story of the Life-or-Death Race for a COVID-19 Vaccine, G. Zuckerman (ISBN-10:‎ 059342039X0) OR
2.) Empire of Pain: The Secret History of the Sackler Dynasty, P Radden Keefe (ISBN-10:‎ 0385545681) OR
3) Bottle of Lies: The inside story of the Generic Drug Boom, K. Eban; (ISBN-10:‎006233879X)
Not open to students who have completed RAQA 459.

5459. Drug Development (991) crn: 6040 (ONLINE) Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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.  
8:30 am - 2:00 pm Saturdays (1/2 hour lunch): May 21, June 4, 18, 25, July 9, 23, 30.  Meets 7 times plus final exam.  Make-up, if needed, Aug 6.
Proctored exam:  July 9 (RPNow)
Faculty:  P. Smith
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. 

5536. Good Clinical Practices (991) crn: 3423 (ONLINE) Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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:  May 17, 24, 31, June 7, 14, 21, 28, July 5, 12, 19, 26, Aug 2. Meets 12 times plus final exam. Make-ups, if needed, Aug 9 and 16.
Proctored exam:  June 28 (RPNow)
Faculty:  J. Hayes
Required text. Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections, 1st Edition by Vera Mihajlovic-Madzarevic; ISBN-13: 978-0470248850
Plus one text from the following three:
           1) Polio: An American Story by D. M. Oshinsky; ISBN-13: 978-0195307146; or
           2) Elixir: The American Tragedy of a Deadly Drug by B. Martin; ISBN-10‏ : ‎0615898173.; or
           3) Frankie: How One Woman Prevented a Pharmaceutical Disaster by J. Essinger; ISBN -10: 1635820464
Not open to students who have completed RAQA 536.

5537.  Clinical Trial Management (990) crn: 5872 (ONLINE) Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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.  
Prerequisite:  Good Clinical Practices (5536) or permission of RAQA Office (include resume with registration).
6:00 pm - 9:00 pm Wednesdays:  May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam.  Make-ups, if needed, Aug 10 and 17.   
Proctored exam:  June 29 (RPNow)
Faculty:  J. Scavone
No required text.
Not open to students who have completed RAQA 537.

5573.  Pharmacoepidemiology (990) crn: 12528  (ONLINE)  Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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 – 9:30 pm Wednesdays:  May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27.  Meets 10 times plus final exam (July 27).  Make-up, if needed, Aug 3 or 10.
Proctored exam: July 27 (RPNow)
Faculty:  N. Cossrow
No required text.
Not open to students who have completed RAQA 570.

5578.  Risk Management and Safety Signaling in Healthcare Products  (990) crn: 12561 Expectations of Online Students  Registration Form for Online Courses 
This course will use PSI Services LLC’s 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.  
Suggestions prerequisite:  One pharmacovigilance course (or forward resume for approval)..
7:00 pm – 10:30 pm Tuesdays: May 17, 24, 31, June 7, 14, 21, 28, July 5, 12, 19. Meets 10 times plus final exam. Make-ups, if needed, July 26 or Aug 2.
Proctored exams: June 21 (RPNow)
Faculty:  To be announced.
No required text.

ELECTIVES – GCPR
5612.  Bioethics for Pharmaceutical Professionals (990) crn: 9538 (ONLINE)  Expectations of Online Students  Registration Form for Online Courses 

This course will use PSI Services LLC’s 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.  
10:00 am – 1:00 pm Saturdays:  May 21, 28 (recording), June 4, 11, 18, 25, July 2 (recording), 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 and 20. 
Proctored exam:  June 25 (RPNow)
Faculty: D. Walsh
Required text: Ethical and Regulatory Aspects of Clinical Research:  Readings and Commentary, Emmanuel, Crouch, Arras, Moreno and Grady, Johns Hopkins University Press, ISBN:  0:0801878136 or 13:9780801878138.
Not open to students who have completed RAQA 610.

To register for the Online courses use:
REGISTRATION FORM for Online 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 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