Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy

image of spilling capsule

Summer 2018 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program

Weekend Courses Only listed numerically by Number


Please check class dates carefully. Students who cannot make the scheduled exam date will be charged a $20.00 fee for an initial makeup exam. The second time the fee increases to $30. Subsequently, the fee increases to $50.00 per exam. For more on this policy, click here.

 

STARTING IN JULY - Register Now!

5579. Legal and Regulatory Basis of Pharmacovigilance (111) crn: 5946
Hands-on experience with Argus Oracle will be included.
Suggested Prerequisite: One Pharmacovigilance course: Either (5571) or (5538) or (5508) or (5578). 

Meets 3 weekends (Saturday and Sunday):
9:30 am – 5:00 pm Sat (1/2 hour lunch): July 14, 28 & Aug 4.
9:30 am – 3:00 pm Sun (1/2 hour lunch): July 15, 29 & Aug 5 (meets until 5:30 pm on Aug 5).
In-class, proctored exam:  Aug 5 (Sunday), 3:30 pm - 5:30 pm
Make-up date, if needed: Saturday, Aug 11.
Faculty: S. Thapar
No required text.

SATURDAYS – BEGINNING May 19

Note:  There is an online section of Drug Development on Saturday mornings starting May 19.

5495.  IND/NDA Submissions (111) crn: 7670
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  May 19, June 2, 9, 23, July 14, 21.  Meets 6 times plus final exam.  No class June 30.  Make-up, if needed, July 28.
In-class, proctored exam:  June 23.
Faculty:  P. Smith
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th edition, (ISGN: 1-882615-85-9).
Not open to students who have completed Pharmaceutics 495.

5538. Clinical Drug Safety and Pharmacovigilance (111) crn: 7673
Hands-on experience with Argus Oracle will be included.
Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): May 19, June 2 & 16.
9:00 am – 2:30 pm Sun (1/2 hour lunch): May 20, June 3 & 17.
Make-up date: June 23 (Saturday)
In-class, proctored exam: Sunday: June 17 or 24
Faculty: S. Thapar
No required text.

5579. Legal and Regulatory Basis of Pharmacovigilance (111) crn: 5946
Hands-on experience with Argus Oracle will be included.
Suggested Prerequisite: One Pharmacovigilance course: Either (5571) or (5538) or (5508) or (5578). 

Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): July 14, 28 & Aug 4.
9:00 am – 2:30 pm Sun (1/2 hour lunch): July 15, 29 & Aug 5.
Make-up date: Aug 11 (Saturday)
In-class, proctored exam: Sunday: Aug 5 or 12.
Faculty: S. Thapar
No required text.

5592.  Food and Drug Law (111) crn:  8587
8:30 am - 3:00 pm Saturdays (1/2 hour lunch): May 19, June 2, 9, 23, 30, July 14. Meets 6 times plus final exam.
Make-up, if needed, July 21.
In-class, proctored exam:  June 23.
Faculty:  B. Berger
Required text: Food and Drug Law: Cases and Materials, 4th ed, Hutt, et al, Foundation Press, (ISBN:  1609301757).  Make sure to purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, (ISBN: 9781634591904).  Note:  a 2012 edition or later of this text is acceptable.
Not open to students who have taken Pharmaceutics 592.

 

SUNDAYS – BEGINNING MAY 20

5477. Good Manufacturing Practices (101) crn:  884
9:00 am - 3:30 pm Sundays (1/2 hour lunch):  May 20, June 3, 10, 24, July 1 (field trip to Almac in Souderton, PA), 15.   Meets 6 times plus final exam including mandatory field trip to Almac (July 1).  Make-up, if needed, July 22.
In-class, proctored exam:  June 24.
Faculty:  T. Ely
No required text.
Not open to students who have completed Pharmaceutics 487.

5538. Clinical Drug Safety and Pharmacovigilance (111) crn: 6738
Hands-on experience with Argus Oracle will be included.
Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): May 19, June 2 & 16.
9:00 am – 2:30 pm Sun (1/2 hour lunch): May 20, June 3 & 17.
Make-up date: June 23 (Saturday)
In-class, proctored exam: Sunday: June 17 or 24
Faculty: S. Thapar
No required text.

5539.  Global Clinical Drug Development (111) crn: 8586
Prerequisite: two of the following courses: Drug Development (5459) or Good Clinical Practices (5536) or Food and Drug Law (5592) or Global Regulatory Affairs (5591).
8:30 am - 5:00 pm Sundays (1 hour lunch):  June 3, 10, 24, July 1, 15.  Meets 5 times plus final exam.  Make-up, if needed, July 22.
In-class, proctored exams:  June 24 and July 15. 
Faculty:  L. Edwards
Required text:  Principles and Practices of Pharmaceutical Medicine, 3rd edition, (ISBN: 978-1-4051-9472-3).
Available on the Paley Library website for registered students: http://vv4kg5gr5v.search.serialssolutions.com/?V=1.0&L=VV4KG5GR5V&S=JCs&C=TC0000441153&T=marc
Not open to students who have taken Pharmaceutics 539.

5579. Legal and Regulatory Basis of Pharmacovigilance (111) crn: 5946
Hands-on experience with Argus Oracle will be included.
Suggested Prerequisite: One Pharmacovigilance course: Either (5571) or (5538) or (5508) or (5578). 
Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): July 14, 28 & Aug 4.
9:00 am – 2:30 pm Sun (1/2 hour lunch): July 15, 29 & Aug 5.
Make-up date: Aug 11 (Saturday)
In-class, proctored exam: Sunday: Aug 5 or 12.
Faculty: S. Thapar
No required text.

 

 

line

Registration Form for Traditional Courses at Fort Washington

How to Register

Is this your first registration with the RAQA program? If so, you must include a RESIDENCY FORM

Is this your fourth class in the RA and QA program? If so, you must include a Non-Matriculated Graduate Student Waiver.

Do you want to apply for the MS in RA and QA? Click here to get started.

PRINT AND FAX YOUR FORMS TO: 267.468.8565

You may also email your forms to: qarareg@temple.edu
or, mail your forms to:

Temple University
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Order texts on-line via: Temple University Ambler Bookstore
 Or, phone: 267.468.8460

Drop/Add Policy

To receive a complete refund for a course, you must notify the RA and QA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.

 

Temple University RA and QA homepage

 
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034-2713
Phone: 267.468.8560
E-Mail:
qara@temple.edu

 

We have changed our name from Quality Assurance/Regulatory Affairs (QA/RA) to the Regulatory Affairs and Quality Assurance Graduate Program (RA and QA) due to Search Engine issues.

This schedule is subject to change.